Measles Clinical Trial
Official title:
Safety and Immunogenicity of Measles Vaccine, Varicella Vaccine and Hepatitis-A Vaccine in HIV-exposed and HIV-unexposed South African Children
This trial will evaluate the safety and immunogenicity of: i) measles vaccine (CAM-70) after primary dose at 6 months (MV1) and booster vaccination at 12 months (MV2); ii) a single dose of varicella vaccination at 18 months; and iii) a single dose of hepatitis-A vaccination at 18 months in HIV-exposed and HIV-unexposed South African children.
Measles vaccine (MV) can reduce childhood mortality and is currently recommended to all South
African children aged 6 months. Only one study has examined the safety and immunogenicity of
the recommended CAM-70 measles vaccine strain in children under 9 months of age. In addition,
there are limited data on the safety and immunogenicity of varicella vaccine (VV) and
Hepatitis-A vaccination (Hep-AV) in HIV-exposed and HIV-unexposed children in Sub-Saharan
Africa.
This is a prospective, observational cohort study nested within a larger randomized,
open-label trial on pneumococcal-conjugate vaccine (PCV) titled PCV1+1. 70 HIV-exposed and
200 HIV-unexposed children will be enrolled at Chris Hani Baragwanath Academic Hospital
(CHBAH) and neighbouring primary health clinics.
Immune responses to the vaccines will be measured as rate of seroconversion, rate of
seroprotection, and geometric mean titres (GMT) one month post primary immunization (MV1, VV,
Hep-AV) and one month post booster dose (MV2). In addition, pre-vaccination and medium
long-term antibody levels at 4.5 months, 12 months and 18 months will be evaluated. Number of
adverse events in all immunized infants will be recorded throughout the study duration and
compared between groups. Long-term antibody levels at 3, 4 and 5 years of age will be
measured during annual follow-up visits.
This study will add to the current evidence on immunizing infants with MV (CAM-70) at 6 and
12 months of age. Data will be stratified by HIV-exposure and HIV-infection, thereby offering
insight in the influence of HIV on post-vaccination immune responses. The findings on
VV/Hep-AV safety, immunogenicity and seroprevalence will be useful to informing future
immunization policies in Sub-Saharan Africa.
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