Evaluation of safety and immunogenicity of a quadrivalent human papillomavirus vaccine in healthy females between 9 and 26 years of age in Sub-Saharan Africa.
Identifieur interne : 000568 ( PubMed/Curation ); précédent : 000567; suivant : 000569Evaluation of safety and immunogenicity of a quadrivalent human papillomavirus vaccine in healthy females between 9 and 26 years of age in Sub-Saharan Africa.
Auteurs : Nelly Mugo [Kenya] ; Nana Akosua Ansah ; Deborah Marino ; Alfred Saah ; Elizabeth I O. GarnerSource :
- Human vaccines & immunotherapeutics [ 2164-554X ] ; 2015.
Descripteurs français
- KwdFr :
- Adolescent, Adulte, Anticorps antiviraux (sang), Effets secondaires indésirables des médicaments (anatomopathologie), Effets secondaires indésirables des médicaments (épidémiologie), Enfant, Femelle, Ghana, Humains, Infections à papillomavirus (), Jeune adulte, Kenya, Méthode en double aveugle, Placebo, Résultat thérapeutique, Sénégal, Vaccin recombinant quadrivalent contre les papillomavirus humains de type 6, 11, 16 et 18 (administration et posologie), Vaccin recombinant quadrivalent contre les papillomavirus humains de type 6, 11, 16 et 18 (effets indésirables), Vaccin recombinant quadrivalent contre les papillomavirus humains de type 6, 11, 16 et 18 (immunologie), Volontaires sains.
- MESH :
- administration et posologie : Vaccin recombinant quadrivalent contre les papillomavirus humains de type 6, 11, 16 et 18.
- anatomopathologie : Effets secondaires indésirables des médicaments.
- effets indésirables : Vaccin recombinant quadrivalent contre les papillomavirus humains de type 6, 11, 16 et 18.
- immunologie : Vaccin recombinant quadrivalent contre les papillomavirus humains de type 6, 11, 16 et 18.
- sang : Anticorps antiviraux.
- épidémiologie : Effets secondaires indésirables des médicaments.
- Adolescent, Adulte, Enfant, Femelle, Ghana, Humains, Infections à papillomavirus, Jeune adulte, Kenya, Méthode en double aveugle, Placebo, Résultat thérapeutique, Sénégal, Volontaires sains.
- Wicri :
English descriptors
- KwdEn :
- Adolescent, Adult, Antibodies, Viral (blood), Child, Double-Blind Method, Drug-Related Side Effects and Adverse Reactions (epidemiology), Drug-Related Side Effects and Adverse Reactions (pathology), Female, Ghana, Healthy Volunteers, Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 (administration & dosage), Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 (adverse effects), Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 (immunology), Humans, Kenya, Papillomavirus Infections (prevention & control), Placebos, Senegal, Treatment Outcome, Young Adult.
- MESH :
- chemical , administration & dosage : Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18.
- chemical , adverse effects : Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18.
- chemical , blood : Antibodies, Viral.
- chemical , immunology : Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18.
- geographic : Ghana, Kenya, Placebos, Senegal.
- epidemiology : Drug-Related Side Effects and Adverse Reactions.
- pathology : Drug-Related Side Effects and Adverse Reactions.
- prevention & control : Papillomavirus Infections.
- Adolescent, Adult, Child, Double-Blind Method, Female, Healthy Volunteers, Humans, Treatment Outcome, Young Adult.
Abstract
Due to sporadic and not easily accessible cervical cancer screening, human papillomavirus (HPV)-related cervical cancer is a leading cause of cancer death in Sub-Saharan African women. This study was designed to assess the safety and immunogenicity of a quadrivalent human papillomavirus (qHPV) vaccine in sub-Saharan African women. This seven month, double-blind study enrolled 250 healthy, human immunodeficiency virus (HIV)-uninfected females ages 9-26 residing in Ghana, Kenya, and Senegal. Thirty females ages 13-15 and 120 females ages 16-26 received qHPV vaccine. In addition, 100 females ages 9-12 y were randomized in a 4:1 ratio to receive either qHPV vaccine (n = 80) or placebo (n = 20 ). The primary immunogenicity hypothesis was that an acceptable percentage of subjects who received the qHPV vaccine seroconvert to HPV6/11/16/18 at 4 weeks post-dose 3, defined as the lower bound of the corresponding 95% confidence interval (CI) exceeding 90%. The primary safety objective was to demonstrate that qHPV vaccine was generally well tolerated when administered in a 3-dose regimen. The pre-specified statistical criterion for the primary immunogenicity hypothesis was met: the lower bound of the 95% exact binomial CI on the seroconversion rate was at least 98% for each vaccine HPV type and all subjects seroconverted by 4 weeks post-dose 3. Across vaccination groups, the most common adverse events (AE) were at the injection site, including pain, swelling, and erythema. No subject discontinued study medication due to an AE and no serious AEs were reported. There were no deaths. This study demonstrated that qHPV vaccination of sub-Saharan African women was highly immunogenic and generally well tolerated.
DOI: 10.1080/21645515.2015.1008877
PubMed: 25912475
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xml:lang="fr"><term>Ghana</term><term>Kenya</term><term>Sénégal</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Due to sporadic and not easily accessible cervical cancer screening, human papillomavirus (HPV)-related cervical cancer is a leading cause of cancer death in Sub-Saharan African women. This study was designed to assess the safety and immunogenicity of a quadrivalent human papillomavirus (qHPV) vaccine in sub-Saharan African women. This seven month, double-blind study enrolled 250 healthy, human immunodeficiency virus (HIV)-uninfected females ages 9-26 residing in Ghana, Kenya, and Senegal. Thirty females ages 13-15 and 120 females ages 16-26 received qHPV vaccine. In addition, 100 females ages 9-12 y were randomized in a 4:1 ratio to receive either qHPV vaccine (n = 80) or placebo (n = 20 ). The primary immunogenicity hypothesis was that an acceptable percentage of subjects who received the qHPV vaccine seroconvert to HPV6/11/16/18 at 4 weeks post-dose 3, defined as the lower bound of the corresponding 95% confidence interval (CI) exceeding 90%. The primary safety objective was to demonstrate that qHPV vaccine was generally well tolerated when administered in a 3-dose regimen. The pre-specified statistical criterion for the primary immunogenicity hypothesis was met: the lower bound of the 95% exact binomial CI on the seroconversion rate was at least 98% for each vaccine HPV type and all subjects seroconverted by 4 weeks post-dose 3. Across vaccination groups, the most common adverse events (AE) were at the injection site, including pain, swelling, and erythema. No subject discontinued study medication due to an AE and no serious AEs were reported. There were no deaths. This study demonstrated that qHPV vaccination of sub-Saharan African women was highly immunogenic and generally well tolerated.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">25912475</PMID><DateCreated><Year>2015</Year><Month>06</Month><Day>19</Day></DateCreated><DateCompleted><Year>2016</Year><Month>03</Month><Day>14</Day></DateCompleted><DateRevised><Year>2017</Year><Month>02</Month><Day>20</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Electronic">2164-554X</ISSN><JournalIssue CitedMedium="Internet"><Volume>11</Volume><Issue>6</Issue><PubDate><Year>2015</Year></PubDate></JournalIssue><Title>Human vaccines & immunotherapeutics</Title><ISOAbbreviation>Hum Vaccin Immunother</ISOAbbreviation></Journal><ArticleTitle>Evaluation of safety and immunogenicity of a quadrivalent human papillomavirus vaccine in healthy females between 9 and 26 years of age in Sub-Saharan Africa.</ArticleTitle><Pagination><MedlinePgn>1323-30</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1080/21645515.2015.1008877</ELocationID><Abstract><AbstractText>Due to sporadic and not easily accessible cervical cancer screening, human papillomavirus (HPV)-related cervical cancer is a leading cause of cancer death in Sub-Saharan African women. This study was designed to assess the safety and immunogenicity of a quadrivalent human papillomavirus (qHPV) vaccine in sub-Saharan African women. This seven month, double-blind study enrolled 250 healthy, human immunodeficiency virus (HIV)-uninfected females ages 9-26 residing in Ghana, Kenya, and Senegal. Thirty females ages 13-15 and 120 females ages 16-26 received qHPV vaccine. In addition, 100 females ages 9-12 y were randomized in a 4:1 ratio to receive either qHPV vaccine (n = 80) or placebo (n = 20 ). The primary immunogenicity hypothesis was that an acceptable percentage of subjects who received the qHPV vaccine seroconvert to HPV6/11/16/18 at 4 weeks post-dose 3, defined as the lower bound of the corresponding 95% confidence interval (CI) exceeding 90%. The primary safety objective was to demonstrate that qHPV vaccine was generally well tolerated when administered in a 3-dose regimen. The pre-specified statistical criterion for the primary immunogenicity hypothesis was met: the lower bound of the 95% exact binomial CI on the seroconversion rate was at least 98% for each vaccine HPV type and all subjects seroconverted by 4 weeks post-dose 3. Across vaccination groups, the most common adverse events (AE) were at the injection site, including pain, swelling, and erythema. No subject discontinued study medication due to an AE and no serious AEs were reported. There were no deaths. This study demonstrated that qHPV vaccination of sub-Saharan African women was highly immunogenic and generally well tolerated.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Mugo</LastName><ForeName>Nelly</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>a Kenyatta National Hospital ; Nairobi , Kenya.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ansah</LastName><ForeName>Nana Akosua</ForeName><Initials>NA</Initials></Author><Author ValidYN="Y"><LastName>Marino</LastName><ForeName>Deborah</ForeName><Initials>D</Initials></Author><Author ValidYN="Y"><LastName>Saah</LastName><ForeName>Alfred</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Garner</LastName><ForeName>Elizabeth I O</ForeName><Initials>EI</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList></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="D000914">Antibodies, Viral</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000068857">Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D010919">Placebos</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>BMC Infect Dis. 2014;14:87</RefSource><PMID Version="1">24552260</PMID></CommentsCorrections><CommentsCorrections 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