Immunogenicity and safety of a hexavalent pediatric vaccine in HIV-exposed infected and uninfected infants in Republic of South Africa
Human immunodeficiency virus (HIV)-exposed infants may be at increased risk of vaccine-preventable disease. This study was conducted as a post-licensure commitment in this population to evaluate the primary series, antibody persistence, and booster response to a licensed fully liquid hexavalent vacc...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2021-06-01
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| Series: | Human Vaccines & Immunotherapeutics |
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| Online Access: | http://dx.doi.org/10.1080/21645515.2020.1839289 |
| _version_ | 1827809568866959360 |
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| author | Anthonet Koen Shabir Madhi Olga Lyabis Emmanuel Vidor Beverley Cowper Thinus Marais Dhaval Patel Claire Vigne |
| author_facet | Anthonet Koen Shabir Madhi Olga Lyabis Emmanuel Vidor Beverley Cowper Thinus Marais Dhaval Patel Claire Vigne |
| author_sort | Anthonet Koen |
| collection | DOAJ |
| description | Human immunodeficiency virus (HIV)-exposed infants may be at increased risk of vaccine-preventable disease. This study was conducted as a post-licensure commitment in this population to evaluate the primary series, antibody persistence, and booster response to a licensed fully liquid hexavalent vaccine containing diphtheria (D), tetanus (T), acellular pertussis (aP), inactivated poliovirus (IPV), hepatitis B (HB), and Haemophilus influenzae type b antigens (PRP~T). This was a Phase III, open-label, randomized study conducted at a single center in the Republic of South Africa. The DTaP-IPV-HB-PRP~T vaccine was administered to HIV-exposed infected (Group A: N = 14) and HIV-exposed uninfected (Group B: N = 50) infants as a 6, 10, 14 week primary series with a toddler booster at 15–18 months of age. Immunogenicity of each antigen was measured using validated assays and vaccine reactogenicity was recorded using diary cards. The low number of HIV-exposed infected participants, due to widespread pre- and peri-natal retroviral treatment, meant that between-group comparisons should be treated with caution. In each group, primary series and booster immune seroprotection rates were strong, and pre-booster antibody persistence was good, although anti-HBs ≥10 mIU/mL in Group A was 78.6% post-primary series, 58.3% pre-booster, and 75.0% post-booster. There were no safety concerns. In conclusion, primary series and booster vaccination of the DTaP-IPV-HB-PRP~T vaccine were immunogenic and safe in HIV-exposed infected and uninfected infants. These results were comparable to historical data in healthy infants and toddlers. |
| first_indexed | 2024-03-11T22:42:20Z |
| format | Article |
| id | doaj.art-f7e00ebe1c3b4a0c8a36ceb15d66c787 |
| institution | Directory Open Access Journal |
| issn | 2164-5515 2164-554X |
| language | English |
| last_indexed | 2024-03-11T22:42:20Z |
| publishDate | 2021-06-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj.art-f7e00ebe1c3b4a0c8a36ceb15d66c7872023-09-22T08:51:52ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2021-06-011761770177810.1080/21645515.2020.18392891839289Immunogenicity and safety of a hexavalent pediatric vaccine in HIV-exposed infected and uninfected infants in Republic of South AfricaAnthonet Koen0Shabir Madhi1Olga Lyabis2Emmanuel Vidor3Beverley Cowper4Thinus Marais5Dhaval Patel6Claire Vigne7University of the WitwatersrandUniversity of the WitwatersrandSanofi PasteurSanofi PasteurSanofi PasteurSanofi PasteurSanofi PasteurSanofi PasteurHuman immunodeficiency virus (HIV)-exposed infants may be at increased risk of vaccine-preventable disease. This study was conducted as a post-licensure commitment in this population to evaluate the primary series, antibody persistence, and booster response to a licensed fully liquid hexavalent vaccine containing diphtheria (D), tetanus (T), acellular pertussis (aP), inactivated poliovirus (IPV), hepatitis B (HB), and Haemophilus influenzae type b antigens (PRP~T). This was a Phase III, open-label, randomized study conducted at a single center in the Republic of South Africa. The DTaP-IPV-HB-PRP~T vaccine was administered to HIV-exposed infected (Group A: N = 14) and HIV-exposed uninfected (Group B: N = 50) infants as a 6, 10, 14 week primary series with a toddler booster at 15–18 months of age. Immunogenicity of each antigen was measured using validated assays and vaccine reactogenicity was recorded using diary cards. The low number of HIV-exposed infected participants, due to widespread pre- and peri-natal retroviral treatment, meant that between-group comparisons should be treated with caution. In each group, primary series and booster immune seroprotection rates were strong, and pre-booster antibody persistence was good, although anti-HBs ≥10 mIU/mL in Group A was 78.6% post-primary series, 58.3% pre-booster, and 75.0% post-booster. There were no safety concerns. In conclusion, primary series and booster vaccination of the DTaP-IPV-HB-PRP~T vaccine were immunogenic and safe in HIV-exposed infected and uninfected infants. These results were comparable to historical data in healthy infants and toddlers.http://dx.doi.org/10.1080/21645515.2020.1839289boosterhexavalenthistorical comparisonhiv-exposedhiv-infectedprimary seriesvaccine |
| spellingShingle | Anthonet Koen Shabir Madhi Olga Lyabis Emmanuel Vidor Beverley Cowper Thinus Marais Dhaval Patel Claire Vigne Immunogenicity and safety of a hexavalent pediatric vaccine in HIV-exposed infected and uninfected infants in Republic of South Africa Human Vaccines & Immunotherapeutics booster hexavalent historical comparison hiv-exposed hiv-infected primary series vaccine |
| title | Immunogenicity and safety of a hexavalent pediatric vaccine in HIV-exposed infected and uninfected infants in Republic of South Africa |
| title_full | Immunogenicity and safety of a hexavalent pediatric vaccine in HIV-exposed infected and uninfected infants in Republic of South Africa |
| title_fullStr | Immunogenicity and safety of a hexavalent pediatric vaccine in HIV-exposed infected and uninfected infants in Republic of South Africa |
| title_full_unstemmed | Immunogenicity and safety of a hexavalent pediatric vaccine in HIV-exposed infected and uninfected infants in Republic of South Africa |
| title_short | Immunogenicity and safety of a hexavalent pediatric vaccine in HIV-exposed infected and uninfected infants in Republic of South Africa |
| title_sort | immunogenicity and safety of a hexavalent pediatric vaccine in hiv exposed infected and uninfected infants in republic of south africa |
| topic | booster hexavalent historical comparison hiv-exposed hiv-infected primary series vaccine |
| url | http://dx.doi.org/10.1080/21645515.2020.1839289 |
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