Long-term follow-up of study participants from prophylactic HIV vaccine clinical trials in Africa.
Identifieur interne : 001438 ( PubMed/Corpus ); précédent : 001437; suivant : 001439Long-term follow-up of study participants from prophylactic HIV vaccine clinical trials in Africa.
Auteurs : Claudia Schmidt ; Walter Jaoko ; Gloria Omosa-Manyonyi ; Pontiano Kaleebu ; Juliet Mpendo ; Annet Nanvubya ; Etienne Karita ; Roger Bayingana ; Linda-Gail Bekker ; Elwyn Chomba ; William Kilembe ; Maphoshane Nchabeleng ; Julien Nyombayire ; Gwynn Stevens ; Paramesh Chetty ; Jennifer Lehrman ; Josephine Cox ; Susan Allen ; Len Dally ; Carol Smith ; Patricia E. FastSource :
- Human vaccines & immunotherapeutics [ 2164-554X ] ; 2014.
English descriptors
- KwdEn :
- AIDS Vaccines (administration & dosage), AIDS Vaccines (adverse effects), AIDS Vaccines (immunology), Adolescent, Adult, Africa (epidemiology), Clinical Trials as Topic, Female, Follow-Up Studies, HIV Infections (epidemiology), HIV Infections (prevention & control), Health Status, Humans, Leukocytes, Mononuclear (immunology), Male, Middle Aged, Pregnancy, Surveys and Questionnaires, Young Adult.
- MESH :
- chemical , administration & dosage : AIDS Vaccines.
- chemical , adverse effects : AIDS Vaccines.
- chemical , immunology : AIDS Vaccines.
- geographic , epidemiology : Africa.
- epidemiology : HIV Infections.
- immunology : Leukocytes, Mononuclear.
- prevention & control : HIV Infections.
- Adolescent, Adult, Clinical Trials as Topic, Female, Follow-Up Studies, Health Status, Humans, Male, Middle Aged, Pregnancy, Surveys and Questionnaires, Young Adult.
Abstract
Long-term safety is critical for the development and later use of a vaccine to prevent HIV/AIDS. Likewise, the persistence of vaccine-induced antibodies and their impact on HIV testing must be established. IAVI has sponsored several Phase I and IIA HIV vaccine trials enrolling healthy, HIV-seronegative African volunteers. Plasmid DNA and viral vector based vaccines were tested. No vaccine-related serious adverse events were reported. After completion of vaccine trials conducted between 2001-2007, both vaccine and placebo recipients were offered enrolment into an observational long-term follow-up study (LTFU) to monitor potential late health effects and persistence of immune responses. At scheduled 6-monthly clinic visits, a health questionnaire was administered; clinical events were recorded and graded for severity. Blood was drawn for HIV testing and cellular immune assays. 287 volunteers were enrolled; total follow-up after last vaccination was 1463 person years (median: 5.2 years). Ninety-three (93)% of volunteers reported good health at their last LTFU visit. Infectious diseases and injuries accounted for almost 50% of the 175 reported clinical events, of which over 95% were mild or moderate in severity. There were 30 six pregnancies, six incident HIV infections and 14 volunteers reported cases of social harm. Persistence of immune responses was rare. No safety signal was identified. No potentially vaccine-related medical condition, no immune mediated disease, or malignancy was reported. HIV vaccines studied in these trials had a low potential of induction of persisting HIV antibodies.
PubMed: 24374365
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pubmed:24374365Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Long-term follow-up of study participants from prophylactic HIV vaccine clinical trials in Africa.</title><author><name sortKey="Schmidt, Claudia" sort="Schmidt, Claudia" uniqKey="Schmidt C" first="Claudia" last="Schmidt">Claudia Schmidt</name><affiliation><nlm:affiliation>International AIDS Vaccine Initiative (IAVI); NY, NY USA.</nlm:affiliation></affiliation></author><author><name sortKey="Jaoko, Walter" sort="Jaoko, Walter" uniqKey="Jaoko W" first="Walter" last="Jaoko">Walter Jaoko</name><affiliation><nlm:affiliation>Kenya AIDS Vaccine Initiative (KAVI); University of Nairobi, Kenya.</nlm:affiliation></affiliation></author><author><name sortKey="Omosa Manyonyi, Gloria" sort="Omosa Manyonyi, Gloria" uniqKey="Omosa Manyonyi G" first="Gloria" last="Omosa-Manyonyi">Gloria Omosa-Manyonyi</name><affiliation><nlm:affiliation>Kenya AIDS Vaccine Initiative (KAVI); University of Nairobi, Kenya.</nlm:affiliation></affiliation></author><author><name sortKey="Kaleebu, Pontiano" sort="Kaleebu, Pontiano" uniqKey="Kaleebu P" first="Pontiano" last="Kaleebu">Pontiano Kaleebu</name><affiliation><nlm:affiliation>UVRI-IAVI HIV Vaccine Program; Entebbe, Uganda.</nlm:affiliation></affiliation></author><author><name sortKey="Mpendo, Juliet" sort="Mpendo, Juliet" uniqKey="Mpendo J" first="Juliet" last="Mpendo">Juliet Mpendo</name><affiliation><nlm:affiliation>UVRI-IAVI HIV Vaccine Program; Entebbe, Uganda.</nlm:affiliation></affiliation></author><author><name sortKey="Nanvubya, Annet" sort="Nanvubya, Annet" uniqKey="Nanvubya A" first="Annet" last="Nanvubya">Annet Nanvubya</name><affiliation><nlm:affiliation>UVRI-IAVI HIV Vaccine Program; Entebbe, Uganda.</nlm:affiliation></affiliation></author><author><name sortKey="Karita, Etienne" sort="Karita, Etienne" uniqKey="Karita E" first="Etienne" last="Karita">Etienne Karita</name><affiliation><nlm:affiliation>Projet San Francisco (PSF); Kigali, Rwanda.</nlm:affiliation></affiliation></author><author><name sortKey="Bayingana, Roger" sort="Bayingana, Roger" uniqKey="Bayingana R" first="Roger" last="Bayingana">Roger Bayingana</name><affiliation><nlm:affiliation>Projet San Francisco (PSF); Kigali, Rwanda.</nlm:affiliation></affiliation></author><author><name sortKey="Bekker, Linda Gail" sort="Bekker, Linda Gail" uniqKey="Bekker L" first="Linda-Gail" last="Bekker">Linda-Gail Bekker</name><affiliation><nlm:affiliation>Desmond Tutu HIV Center (DTHC); Cape Town, South Africa.</nlm:affiliation></affiliation></author><author><name sortKey="Chomba, Elwyn" sort="Chomba, Elwyn" uniqKey="Chomba E" first="Elwyn" last="Chomba">Elwyn Chomba</name><affiliation><nlm:affiliation>Zambia Emory HIV Research Program (ZEHRP); Lusaka, Zambia.</nlm:affiliation></affiliation></author><author><name sortKey="Kilembe, William" sort="Kilembe, William" uniqKey="Kilembe W" first="William" last="Kilembe">William Kilembe</name><affiliation><nlm:affiliation>Zambia Emory HIV Research Program (ZEHRP); Lusaka, Zambia.</nlm:affiliation></affiliation></author><author><name sortKey="Nchabeleng, Maphoshane" sort="Nchabeleng, Maphoshane" uniqKey="Nchabeleng M" first="Maphoshane" last="Nchabeleng">Maphoshane Nchabeleng</name><affiliation><nlm:affiliation>Department of Medical Microbiology; University of Limpopo, Medunsa Campus; Pretoria, South Africa.</nlm:affiliation></affiliation></author><author><name sortKey="Nyombayire, Julien" sort="Nyombayire, Julien" uniqKey="Nyombayire J" first="Julien" last="Nyombayire">Julien Nyombayire</name><affiliation><nlm:affiliation>Projet San Francisco (PSF); Kigali, Rwanda.</nlm:affiliation></affiliation></author><author><name sortKey="Stevens, Gwynn" sort="Stevens, Gwynn" uniqKey="Stevens G" first="Gwynn" last="Stevens">Gwynn Stevens</name><affiliation><nlm:affiliation>IAVI; Clinical (Immunology) Laboratory; Parktown, South Africa.</nlm:affiliation></affiliation></author><author><name sortKey="Chetty, Paramesh" sort="Chetty, Paramesh" uniqKey="Chetty P" first="Paramesh" last="Chetty">Paramesh Chetty</name><affiliation><nlm:affiliation>IAVI; Clinical (Immunology) Laboratory; Parktown, South Africa.</nlm:affiliation></affiliation></author><author><name sortKey="Lehrman, Jennifer" sort="Lehrman, Jennifer" uniqKey="Lehrman J" first="Jennifer" last="Lehrman">Jennifer Lehrman</name><affiliation><nlm:affiliation>International AIDS Vaccine Initiative (IAVI); NY, NY USA.</nlm:affiliation></affiliation></author><author><name sortKey="Cox, Josephine" sort="Cox, Josephine" uniqKey="Cox J" first="Josephine" last="Cox">Josephine Cox</name><affiliation><nlm:affiliation>IAVI; Human Immunology Laboratory (HIL); Imperial College; London, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Allen, Susan" sort="Allen, Susan" uniqKey="Allen S" first="Susan" last="Allen">Susan Allen</name><affiliation><nlm:affiliation>Emory University; Atlanta, GA USA.</nlm:affiliation></affiliation></author><author><name sortKey="Dally, Len" sort="Dally, Len" uniqKey="Dally L" first="Len" last="Dally">Len Dally</name><affiliation><nlm:affiliation>EMMES: The EMMES Corporation; Rockville, MD USA.</nlm:affiliation></affiliation></author><author><name sortKey="Smith, Carol" sort="Smith, Carol" uniqKey="Smith C" first="Carol" last="Smith">Carol Smith</name><affiliation><nlm:affiliation>EMMES: The EMMES Corporation; Rockville, MD USA.</nlm:affiliation></affiliation></author><author><name sortKey="Fast, Patricia E" sort="Fast, Patricia E" uniqKey="Fast P" first="Patricia E" last="Fast">Patricia E. Fast</name><affiliation><nlm:affiliation>International AIDS Vaccine Initiative (IAVI); NY, NY USA.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2014">2014</date><idno type="RBID">pubmed:24374365</idno><idno type="pmid">24374365</idno><idno type="wicri:Area/PubMed/Corpus">001438</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">001438</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Long-term follow-up of study participants from prophylactic HIV vaccine clinical trials in Africa.</title><author><name sortKey="Schmidt, Claudia" sort="Schmidt, Claudia" uniqKey="Schmidt C" first="Claudia" last="Schmidt">Claudia Schmidt</name><affiliation><nlm:affiliation>International AIDS Vaccine Initiative (IAVI); NY, NY USA.</nlm:affiliation></affiliation></author><author><name sortKey="Jaoko, Walter" sort="Jaoko, Walter" uniqKey="Jaoko W" first="Walter" last="Jaoko">Walter Jaoko</name><affiliation><nlm:affiliation>Kenya AIDS Vaccine Initiative (KAVI); University of Nairobi, Kenya.</nlm:affiliation></affiliation></author><author><name sortKey="Omosa Manyonyi, Gloria" sort="Omosa Manyonyi, Gloria" uniqKey="Omosa Manyonyi G" first="Gloria" last="Omosa-Manyonyi">Gloria Omosa-Manyonyi</name><affiliation><nlm:affiliation>Kenya AIDS Vaccine Initiative (KAVI); University of Nairobi, Kenya.</nlm:affiliation></affiliation></author><author><name sortKey="Kaleebu, Pontiano" sort="Kaleebu, Pontiano" uniqKey="Kaleebu P" first="Pontiano" last="Kaleebu">Pontiano Kaleebu</name><affiliation><nlm:affiliation>UVRI-IAVI HIV Vaccine Program; Entebbe, Uganda.</nlm:affiliation></affiliation></author><author><name sortKey="Mpendo, Juliet" sort="Mpendo, Juliet" uniqKey="Mpendo J" first="Juliet" last="Mpendo">Juliet Mpendo</name><affiliation><nlm:affiliation>UVRI-IAVI HIV Vaccine Program; Entebbe, Uganda.</nlm:affiliation></affiliation></author><author><name sortKey="Nanvubya, Annet" sort="Nanvubya, Annet" uniqKey="Nanvubya A" first="Annet" last="Nanvubya">Annet Nanvubya</name><affiliation><nlm:affiliation>UVRI-IAVI HIV Vaccine Program; Entebbe, Uganda.</nlm:affiliation></affiliation></author><author><name sortKey="Karita, Etienne" sort="Karita, Etienne" uniqKey="Karita E" first="Etienne" last="Karita">Etienne Karita</name><affiliation><nlm:affiliation>Projet San Francisco (PSF); Kigali, Rwanda.</nlm:affiliation></affiliation></author><author><name sortKey="Bayingana, Roger" sort="Bayingana, Roger" uniqKey="Bayingana R" first="Roger" last="Bayingana">Roger Bayingana</name><affiliation><nlm:affiliation>Projet San Francisco (PSF); Kigali, Rwanda.</nlm:affiliation></affiliation></author><author><name sortKey="Bekker, Linda Gail" sort="Bekker, Linda Gail" uniqKey="Bekker L" first="Linda-Gail" last="Bekker">Linda-Gail Bekker</name><affiliation><nlm:affiliation>Desmond Tutu HIV Center (DTHC); Cape Town, South Africa.</nlm:affiliation></affiliation></author><author><name sortKey="Chomba, Elwyn" sort="Chomba, Elwyn" uniqKey="Chomba E" first="Elwyn" last="Chomba">Elwyn Chomba</name><affiliation><nlm:affiliation>Zambia Emory HIV Research Program (ZEHRP); Lusaka, Zambia.</nlm:affiliation></affiliation></author><author><name sortKey="Kilembe, William" sort="Kilembe, William" uniqKey="Kilembe W" first="William" last="Kilembe">William Kilembe</name><affiliation><nlm:affiliation>Zambia Emory HIV Research Program (ZEHRP); Lusaka, Zambia.</nlm:affiliation></affiliation></author><author><name sortKey="Nchabeleng, Maphoshane" sort="Nchabeleng, Maphoshane" uniqKey="Nchabeleng M" first="Maphoshane" last="Nchabeleng">Maphoshane Nchabeleng</name><affiliation><nlm:affiliation>Department of Medical Microbiology; University of Limpopo, Medunsa Campus; Pretoria, South Africa.</nlm:affiliation></affiliation></author><author><name sortKey="Nyombayire, Julien" sort="Nyombayire, Julien" uniqKey="Nyombayire J" first="Julien" last="Nyombayire">Julien Nyombayire</name><affiliation><nlm:affiliation>Projet San Francisco (PSF); Kigali, Rwanda.</nlm:affiliation></affiliation></author><author><name sortKey="Stevens, Gwynn" sort="Stevens, Gwynn" uniqKey="Stevens G" first="Gwynn" last="Stevens">Gwynn Stevens</name><affiliation><nlm:affiliation>IAVI; Clinical (Immunology) Laboratory; Parktown, South Africa.</nlm:affiliation></affiliation></author><author><name sortKey="Chetty, Paramesh" sort="Chetty, Paramesh" uniqKey="Chetty P" first="Paramesh" last="Chetty">Paramesh Chetty</name><affiliation><nlm:affiliation>IAVI; Clinical (Immunology) Laboratory; Parktown, South Africa.</nlm:affiliation></affiliation></author><author><name sortKey="Lehrman, Jennifer" sort="Lehrman, Jennifer" uniqKey="Lehrman J" first="Jennifer" last="Lehrman">Jennifer Lehrman</name><affiliation><nlm:affiliation>International AIDS Vaccine Initiative (IAVI); NY, NY USA.</nlm:affiliation></affiliation></author><author><name sortKey="Cox, Josephine" sort="Cox, Josephine" uniqKey="Cox J" first="Josephine" last="Cox">Josephine Cox</name><affiliation><nlm:affiliation>IAVI; Human Immunology Laboratory (HIL); Imperial College; London, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Allen, Susan" sort="Allen, Susan" uniqKey="Allen S" first="Susan" last="Allen">Susan Allen</name><affiliation><nlm:affiliation>Emory University; Atlanta, GA USA.</nlm:affiliation></affiliation></author><author><name sortKey="Dally, Len" sort="Dally, Len" uniqKey="Dally L" first="Len" last="Dally">Len Dally</name><affiliation><nlm:affiliation>EMMES: The EMMES Corporation; Rockville, MD USA.</nlm:affiliation></affiliation></author><author><name sortKey="Smith, Carol" sort="Smith, Carol" uniqKey="Smith C" first="Carol" last="Smith">Carol Smith</name><affiliation><nlm:affiliation>EMMES: The EMMES Corporation; Rockville, MD USA.</nlm:affiliation></affiliation></author><author><name sortKey="Fast, Patricia E" sort="Fast, Patricia E" uniqKey="Fast P" first="Patricia E" last="Fast">Patricia E. Fast</name><affiliation><nlm:affiliation>International AIDS Vaccine Initiative (IAVI); NY, NY USA.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Human vaccines & immunotherapeutics</title><idno type="eISSN">2164-554X</idno><imprint><date when="2014" type="published">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>AIDS Vaccines (administration & dosage)</term><term>AIDS Vaccines (adverse effects)</term><term>AIDS Vaccines (immunology)</term><term>Adolescent</term><term>Adult</term><term>Africa (epidemiology)</term><term>Clinical Trials as Topic</term><term>Female</term><term>Follow-Up Studies</term><term>HIV Infections (epidemiology)</term><term>HIV Infections (prevention & control)</term><term>Health Status</term><term>Humans</term><term>Leukocytes, Mononuclear (immunology)</term><term>Male</term><term>Middle Aged</term><term>Pregnancy</term><term>Surveys and Questionnaires</term><term>Young Adult</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>AIDS Vaccines</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>AIDS Vaccines</term></keywords><keywords scheme="MESH" type="chemical" qualifier="immunology" xml:lang="en"><term>AIDS Vaccines</term></keywords><keywords scheme="MESH" type="geographic" qualifier="epidemiology" xml:lang="en"><term>Africa</term></keywords><keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>HIV Infections</term></keywords><keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Leukocytes, Mononuclear</term></keywords><keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>HIV Infections</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Clinical Trials as Topic</term><term>Female</term><term>Follow-Up Studies</term><term>Health Status</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Pregnancy</term><term>Surveys and Questionnaires</term><term>Young Adult</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Long-term safety is critical for the development and later use of a vaccine to prevent HIV/AIDS. Likewise, the persistence of vaccine-induced antibodies and their impact on HIV testing must be established. IAVI has sponsored several Phase I and IIA HIV vaccine trials enrolling healthy, HIV-seronegative African volunteers. Plasmid DNA and viral vector based vaccines were tested. No vaccine-related serious adverse events were reported. After completion of vaccine trials conducted between 2001-2007, both vaccine and placebo recipients were offered enrolment into an observational long-term follow-up study (LTFU) to monitor potential late health effects and persistence of immune responses. At scheduled 6-monthly clinic visits, a health questionnaire was administered; clinical events were recorded and graded for severity. Blood was drawn for HIV testing and cellular immune assays. 287 volunteers were enrolled; total follow-up after last vaccination was 1463 person years (median: 5.2 years). Ninety-three (93)% of volunteers reported good health at their last LTFU visit. Infectious diseases and injuries accounted for almost 50% of the 175 reported clinical events, of which over 95% were mild or moderate in severity. There were 30 six pregnancies, six incident HIV infections and 14 volunteers reported cases of social harm. Persistence of immune responses was rare. No safety signal was identified. No potentially vaccine-related medical condition, no immune mediated disease, or malignancy was reported. HIV vaccines studied in these trials had a low potential of induction of persisting HIV antibodies.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">24374365</PMID><DateCreated><Year>2014</Year><Month>08</Month><Day>01</Day></DateCreated><DateCompleted><Year>2015</Year><Month>03</Month><Day>30</Day></DateCompleted><DateRevised><Year>2017</Year><Month>09</Month><Day>22</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">2164-554X</ISSN><JournalIssue CitedMedium="Internet"><Volume>10</Volume><Issue>3</Issue><PubDate><Year>2014</Year></PubDate></JournalIssue><Title>Human vaccines & immunotherapeutics</Title><ISOAbbreviation>Hum Vaccin Immunother</ISOAbbreviation></Journal><ArticleTitle>Long-term follow-up of study participants from prophylactic HIV vaccine clinical trials in Africa.</ArticleTitle><Pagination><MedlinePgn>714-23</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">27559</ELocationID><Abstract><AbstractText>Long-term safety is critical for the development and later use of a vaccine to prevent HIV/AIDS. Likewise, the persistence of vaccine-induced antibodies and their impact on HIV testing must be established. IAVI has sponsored several Phase I and IIA HIV vaccine trials enrolling healthy, HIV-seronegative African volunteers. Plasmid DNA and viral vector based vaccines were tested. No vaccine-related serious adverse events were reported. After completion of vaccine trials conducted between 2001-2007, both vaccine and placebo recipients were offered enrolment into an observational long-term follow-up study (LTFU) to monitor potential late health effects and persistence of immune responses. At scheduled 6-monthly clinic visits, a health questionnaire was administered; clinical events were recorded and graded for severity. Blood was drawn for HIV testing and cellular immune assays. 287 volunteers were enrolled; total follow-up after last vaccination was 1463 person years (median: 5.2 years). Ninety-three (93)% of volunteers reported good health at their last LTFU visit. Infectious diseases and injuries accounted for almost 50% of the 175 reported clinical events, of which over 95% were mild or moderate in severity. There were 30 six pregnancies, six incident HIV infections and 14 volunteers reported cases of social harm. Persistence of immune responses was rare. No safety signal was identified. No potentially vaccine-related medical condition, no immune mediated disease, or malignancy was reported. HIV vaccines studied in these trials had a low potential of induction of persisting HIV antibodies.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Schmidt</LastName><ForeName>Claudia</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>International AIDS Vaccine Initiative (IAVI); NY, NY USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jaoko</LastName><ForeName>Walter</ForeName><Initials>W</Initials><AffiliationInfo><Affiliation>Kenya AIDS Vaccine Initiative (KAVI); University of Nairobi, Kenya.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Omosa-Manyonyi</LastName><ForeName>Gloria</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Kenya AIDS Vaccine Initiative (KAVI); University of Nairobi, Kenya.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kaleebu</LastName><ForeName>Pontiano</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>UVRI-IAVI HIV Vaccine Program; Entebbe, Uganda.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mpendo</LastName><ForeName>Juliet</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>UVRI-IAVI HIV Vaccine Program; Entebbe, Uganda.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Nanvubya</LastName><ForeName>Annet</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>UVRI-IAVI HIV Vaccine Program; Entebbe, Uganda.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Karita</LastName><ForeName>Etienne</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Projet San Francisco (PSF); Kigali, Rwanda.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bayingana</LastName><ForeName>Roger</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Projet San Francisco (PSF); Kigali, Rwanda.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bekker</LastName><ForeName>Linda-Gail</ForeName><Initials>LG</Initials><AffiliationInfo><Affiliation>Desmond Tutu HIV Center (DTHC); Cape Town, South Africa.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chomba</LastName><ForeName>Elwyn</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Zambia Emory HIV Research Program (ZEHRP); Lusaka, Zambia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kilembe</LastName><ForeName>William</ForeName><Initials>W</Initials><AffiliationInfo><Affiliation>Zambia Emory HIV Research Program (ZEHRP); Lusaka, Zambia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Nchabeleng</LastName><ForeName>Maphoshane</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Department of Medical Microbiology; University of Limpopo, Medunsa Campus; Pretoria, South Africa.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Nyombayire</LastName><ForeName>Julien</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Projet San Francisco (PSF); Kigali, Rwanda.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Stevens</LastName><ForeName>Gwynn</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>IAVI; Clinical (Immunology) Laboratory; Parktown, South Africa.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chetty</LastName><ForeName>Paramesh</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>IAVI; Clinical (Immunology) Laboratory; Parktown, South Africa.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lehrman</LastName><ForeName>Jennifer</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>International AIDS Vaccine Initiative (IAVI); NY, NY USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Cox</LastName><ForeName>Josephine</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>IAVI; Human Immunology Laboratory (HIL); Imperial College; London, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Allen</LastName><ForeName>Susan</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Emory University; Atlanta, GA USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dally</LastName><ForeName>Len</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>EMMES: The EMMES Corporation; Rockville, MD USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Smith</LastName><ForeName>Carol</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>EMMES: The EMMES Corporation; Rockville, MD USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Fast</LastName><ForeName>Patricia E</ForeName><Initials>PE</Initials><AffiliationInfo><Affiliation>International AIDS Vaccine Initiative (IAVI); NY, NY USA.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><GrantList CompleteYN="Y"><Grant><GrantID>MC_U950080938</GrantID><Agency>Medical Research Council</Agency><Country>United Kingdom</Country></Grant><Grant><GrantID>MC_U950097145</GrantID><Agency>Medical Research Council</Agency><Country>United Kingdom</Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D064888">Observational Study</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType><PublicationType UI="D013486">Research Support, U.S. Gov't, Non-P.H.S.</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2013</Year><Month>12</Month><Day>27</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Hum Vaccin Immunother</MedlineTA><NlmUniqueID>101572652</NlmUniqueID><ISSNLinking>2164-5515</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D016915">AIDS Vaccines</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>PLoS One. 2012;7(8):e41936</RefSource><PMID Version="1">22870265</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>J Clin Virol. 2011 Apr;50(4):334-7</RefSource><PMID Version="1">21300566</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>PLoS One. 2013;8(1):e54407</RefSource><PMID Version="1">23349878</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>MMWR Morb Mortal Wkly Rep. 2003 Mar 28;52(12):248-50</RefSource><PMID Version="1">12680519</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Vaccine. 2003 Jun 20;21(21-22):2933-47</RefSource><PMID Version="1">12798637</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>MMWR Morb Mortal Wkly Rep. 2003 May 30;52(21):492-6</RefSource><PMID Version="1">12809110</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Vaccine. 2007 Mar 1;25(11):2120-7</RefSource><PMID Version="1">17250931</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Vaccine. 2008 May 23;26(22):2788-95</RefSource><PMID Version="1">18440674</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Clin Vaccine Immunol. 2009 Feb;16(2):147-55</RefSource><PMID Version="1">19091991</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>AIDS Res Hum Retroviruses. 2009 Nov;25(11):1107-16</RefSource><PMID Version="1">19943789</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>PLoS One. 2010;5(1):e8816</RefSource><PMID Version="1">20111599</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>JAMA. 2010 Jul 21;304(3):275-83</RefSource><PMID Version="1">20639561</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>AIDS Res Hum Retroviruses. 2010 Aug;26(8):933-42</RefSource><PMID Version="1">20666584</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>PLoS One. 2010;5(9):e12873</RefSource><PMID Version="1">20877623</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Hum Vaccin Immunother. 2012 May;8(5):630-8</RefSource><PMID Version="1">22634443</PMID></CommentsCorrections></CommentsCorrectionsList><MeshHeadingList><MeshHeading><DescriptorName UI="D016915" MajorTopicYN="N">AIDS Vaccines</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName><QualifierName UI="Q000276" 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control</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006304" MajorTopicYN="N">Health Status</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007963" MajorTopicYN="N">Leukocytes, Mononuclear</DescriptorName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011247" MajorTopicYN="N">Pregnancy</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011795" MajorTopicYN="N">Surveys and Questionnaires</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D055815" MajorTopicYN="N">Young Adult</DescriptorName></MeshHeading></MeshHeadingList><OtherID Source="NLM">PMC4130282</OtherID><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Africa</Keyword><Keyword MajorTopicYN="N">HIV vaccine trials</Keyword><Keyword MajorTopicYN="N">healthy adult volunteers</Keyword><Keyword MajorTopicYN="N">long term follow-up</Keyword><Keyword MajorTopicYN="N">safety</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2013</Year><Month>12</Month><Day>31</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2014</Year><Month>1</Month><Day>1</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2015</Year><Month>3</Month><Day>31</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">24374365</ArticleId><ArticleId IdType="pii">27559</ArticleId><ArticleId 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