NCT03330171

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
278

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2017

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2017

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2019

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

1.9 years

First QC Date

October 12, 2017

Last Update Submit

March 15, 2020

Conditions

MeaslesVaricellaHepatitis A

Keywords

ImmunogenicitySafetyVaccine

Outcome Measures

Primary Outcomes (1)

  • Number of participants with seroprotective antibody titres (IgG ≥330 mIU/ml quantified by ELISA) one month post booster measles vaccination

    Measured as seroprotection rate one month post booster measles vaccine in HIV-exposed (HEU, HIV-infected) and HIV-unexposed South African children.

    13 months of age (one month post booster measles vaccine)

Secondary Outcomes (7)

  • Number of participants with seroprotective antibody titres (IgG ≥300 mIU/ml quantified by ELISA) one month post varicella vaccination

    19 months of age (one month post vaccination)

  • Number of participants with seroprotective antibody titres (IgG ≥20 mIU/ml quantified by ELISA) one month post hepatitis-A vaccination

    19 months of age (one month post vaccination)

  • Number of participants with vaccine-related adverse events after primary measles vaccination

    6 months of age

  • Number of participants with vaccine-related adverse events after booster measles vaccination

    12 months of age

  • Number of participants with vaccine-related adverse events after varicella vaccination

    18 months of age

  • +2 more secondary outcomes

Study Arms (2)

HIV-unexposed children

OTHER

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.

Biological: Measles vaccineBiological: Hepatitis-A vaccineBiological: Varicella vaccine

HIV-exposed children

OTHER

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.

Biological: Measles vaccineBiological: Hepatitis-A vaccineBiological: Varicella vaccine

Interventions

Measles vaccineBIOLOGICAL

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.

Also known as: Measles vaccine (MeasBio) 0.5 mL
HIV-exposed childrenHIV-unexposed children
Hepatitis-A vaccineBIOLOGICAL

Half of the participants (n=135) will receive hepatitis-A vaccine at 18 months of age.

Also known as: Hepatitis-A vaccine (Varilrix) 0.5 mL
HIV-exposed childrenHIV-unexposed children
Varicella vaccineBIOLOGICAL

Half of the participants (n=135) will receive varicella vaccine at 18 months of age.

Also known as: Varicella vaccine (Avaxim Paediatric) 0.5 mL
HIV-exposed childrenHIV-unexposed children

Eligibility Criteria

Age18 Weeks - 19 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chris Hani Baragwanath Academic Hospital; Nrf/Dst Vpd Rmpru

Soweto, Gauteng, 2013, South Africa

Location

Related Publications (3)

  • Mutsaerts EAML, van Cranenbroek B, Madhi SA, Simonetti E, Arns AJ, Jose L, Koen A, van Herwaarden AE, de Jonge MI, Verhagen LM. Impact of nutritional status on vaccine-induced immunity in children living in South Africa: Investigating the B-cell repertoire and metabolic hormones. Vaccine. 2024 May 22;42(14):3337-3345. doi: 10.1016/j.vaccine.2024.04.034. Epub 2024 Apr 17.

    PMID: 38637212DERIVED

  • Mutsaerts EAML, Nunes MC, Bhikha S, Ikulinda BT, Jose L, Koen A, Moultrie A, Grobbee DE, Klipstein-Grobusch K, Weinberg A, Madhi SA. Short-term immunogenicity and safety of hepatitis-A and varicella vaccines in HIV-exposed uninfected and HIV-unexposed South African children. Vaccine. 2020 May 8;38(22):3862-3868. doi: 10.1016/j.vaccine.2020.03.045. Epub 2020 Apr 16.

    PMID: 32307279DERIVED

  • Mutsaerts EAML, Nunes MC, Bhikha S, Ikulinda BT, Boyce W, Jose L, Koen A, Moultrie A, Cutland CL, Grobbee DE, Klipstein-Grobusch K, Madhi SA. Immunogenicity and Safety of an Early Measles Vaccination Schedule at 6 and 12 Months of Age in Human Immunodeficiency Virus (HIV)-Unexposed and HIV-Exposed, Uninfected South African Children. J Infect Dis. 2019 Sep 26;220(9):1529-1538. doi: 10.1093/infdis/jiz348.

    PMID: 31282539DERIVED

MeSH Terms

Conditions

MeaslesChickenpoxHepatitis A

Interventions

Measles VaccineHepatitis A VaccinesChickenpox Vaccine

Condition Hierarchy (Ancestors)

Morbillivirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsVaricella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsHepatitis, Viral, HumanEnterovirus InfectionsPicornaviridae InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex MixturesViral Hepatitis VaccinesHerpesvirus Vaccines

Study Officials

  • Shabir A Madhi, MD, PhD

    University of Witwatersrand, South Africa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Participants receive measles vaccine as part of routine medical care at 6 and 12 months of age. Half of the participants will receive varicella vaccine at 18 months of age and the other half will receive hepatitis-A at 18 months of age. All vaccines are administered according to their approved dosages, formulations and indications.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

October 12, 2017

First Posted

November 6, 2017

Study Start

April 10, 2017

Primary Completion

February 26, 2019

Study Completion

December 1, 2022

Last Updated

March 17, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Currently no plan to share IPD.

Locations

ZA(1)