Safety and Immunogenicity of Measles Vaccine, Varicella Vaccine and Hepatitis-A Vaccine (MV/VV/Hep-AV)
Measles, Varicella, Hepatitis A
About this trial
This is an interventional prevention trial for Measles focused on measuring Immunogenicity, Safety, Vaccine
Eligibility Criteria
Inclusion Criteria:
- Aged ≤18 weeks;
- Parent/guardian able to provide informed consent;
- Available for the duration of the study;
- Enrolled as a participant in the PVC1+1 trial AND born to HIV-uninfected woman; OR Born to HIV-infected mother AND infant CD4% ≥25% if HIV-infected;
- Birth weight >2499g AND weight of >3.5 kg at time of proposed enrolment;
- Being a healthy child (except for HIV status in HIV-exposed cohort) based on medical history and physical examination by the study staff.
Exclusion Criteria:
- Significant major congenital abnormalities;
- Received measles vaccination, varicella vaccination or hepatitis-A vaccination since birth;
- Previous hospitalization for respiratory illness following discharge from hospital at birth;
- Known allergy to vaccine components;
- Febrile illness (axillary temperature ≥37.8°C) at time of screening;
- Known or suspected immunodeficiency condition other than HIV;
- Planning to relocate outside of the study area during the study period;
- Receipt of blood transfusion or any other blood products (including immunoglobulins) since birth, receipt of such products during the course of the study will require withdrawal of the child from the study;
- History of confirmed measles, varicella or hepatitis-A disease since birth.
Sites / Locations
- Chris Hani Baragwanath Academic Hospital; Nrf/Dst Vpd Rmpru
Arms of the Study
Arm 1
Arm 2
Other
Other
HIV-unexposed children
HIV-exposed children
HIV-unexposed children enrolled in a randomized open label study on the pneumococcal conjugate vaccine (PCV1+1) will be invited to participate in this study. Children enrolled in the PCV1+1 study will receive all vaccines included in the South African public immunization program. Measles vaccine (0.5 mL, subcutaneous injection) will be adminstered at 6 months of age and 12 months of age. Varicella vaccine (0.5 mL, subcutaneous injection) or Hepatitis-A vaccine (0.5 mL, intra-muscular injection) will be administered to the participants at 18 months of age as an additional benefit for participating in the study.
A cohort of HIV-exposed children will be recruited. Measles vaccine (0.5 mL, subcutaneous injection) will be adminstered at 6 months of age and 12 months of age. Varicella vaccine (0.5 mL, subcutaneous injection) or Hepatitis-A vaccine (0.5 mL, intra-muscular injection) will be administered to the participants at 18 months of age as an additional benefit for participating in the study.