NCT03330171

Safety and Immunogenicity of Measles Vaccine, Varicella Vaccine and Hepatitis-A Vaccine

Safety and Immunogenicity of Measles Vaccine, Varicella Vaccine and Hepatitis-A Vaccine in HIV-exposed and HIV-unexposed South African Children

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 278 (actual)
• Sponsor: University of Witwatersrand, South Africa · Academic / Other
• Sex: All
• Age: 18 Weeks – 19 Months
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Measles
• Varicella
• Hepatitis A

Interventions

Type	Name	Description
BIOLOGICAL	Measles vaccine	All participants will receive measles vaccine at 6 and 12 months of age, according to the South African immunization schedule. All study vaccines are currently licensed in South Africa and will be administered according to their approved dosages, formulations and indications.
BIOLOGICAL	Hepatitis-A vaccine	Half of the participants (n=135) will receive hepatitis-A vaccine at 18 months of age.
BIOLOGICAL	Varicella vaccine	Half of the participants (n=135) will receive varicella vaccine at 18 months of age.

Timeline

• Start date: 2017-04-10
• Primary completion: 2019-02-26
• Completion: 2022-12-01
• First posted: 2017-11-06
• Last updated: 2020-03-17

Locations

1 site across 1 country: South Africa