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Safety and Immunogenicity of Measles Vaccine, Varicella Vaccine and Hepatitis-A Vaccine (MV/VV/Hep-AV)

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ClinicalTrials.gov Identifier: NCT03330171
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Shabir Madhi, University of Witwatersrand, South Africa

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.

Condition or disease Intervention/treatment Phase
Measles Varicella Hepatitis A Biological: Measles vaccine Biological: Hepatitis-A vaccine Biological: Varicella vaccine Phase 4

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.

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of Measles Vaccine, Varicella Vaccine and Hepatitis-A Vaccine in HIV-exposed and HIV-unexposed South African Children
Actual Study Start Date : April 10, 2017
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : June 2019


Arm Intervention/treatment
HIV-unexposed 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.
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.
Other Name: Measles vaccine (MeasBio) 0.5 mL

Biological: Hepatitis-A vaccine
Half of the participants (n=135) will receive hepatitis-A vaccine at 18 months of age.
Other Name: Hepatitis-A vaccine (Varilrix) 0.5 mL

Biological: Varicella vaccine
Half of the participants (n=135) will receive varicella vaccine at 18 months of age.
Other Name: Varicella vaccine (Avaxim Paediatric) 0.5 mL

HIV-exposed children
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 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.
Other Name: Measles vaccine (MeasBio) 0.5 mL

Biological: Hepatitis-A vaccine
Half of the participants (n=135) will receive hepatitis-A vaccine at 18 months of age.
Other Name: Hepatitis-A vaccine (Varilrix) 0.5 mL

Biological: Varicella vaccine
Half of the participants (n=135) will receive varicella vaccine at 18 months of age.
Other Name: Varicella vaccine (Avaxim Paediatric) 0.5 mL




Primary Outcome Measures :
  1. Number of participants with seroprotective antibody titres (IgG ≥330 mIU/ml quantified by ELISA) one month post booster measles vaccination [ Time Frame: 13 months of age (one month post booster measles vaccine) ]
    Measured as seroprotection rate one month post booster measles vaccine in HIV-exposed (HEU, HIV-infected) and HIV-unexposed South African children.


Secondary Outcome Measures :
  1. Number of participants with seroprotective antibody titres (IgG ≥300 mIU/ml quantified by ELISA) one month post varicella vaccination [ Time Frame: 19 months of age (one month post vaccination) ]
    Measured as seroprotection rate one month post varicella immunization in HIV-exposed (HEU, HIV-infected) and HIV-unexposed South African children.

  2. Number of participants with seroprotective antibody titres (IgG ≥20 mIU/ml quantified by ELISA) one month post hepatitis-A vaccination [ Time Frame: 19 months of age (one month post vaccination) ]
    Measured as seroprotection rate one month post hepatitis-A immunization in HIV-exposed (HEU, HIV-infected) and HIV-unexposed South African children.

  3. Number of participants with vaccine-related adverse events after primary measles vaccination [ Time Frame: 6 months of age ]
    Participants will be observed for at least 30 minutes after vaccination so that clinic personnel can observe and document any potential adverse reactions to the vaccine. Report of vaccine-related local (redness, swelling, pain/tenderness, itching) and systemic (fever, vomiting, poor appetite, irritability and decreased activity) adverse events will be solicited using diary card in the 7 days after vaccination.

  4. Number of participants with vaccine-related adverse events after booster measles vaccination [ Time Frame: 12 months of age ]
    Participants will be observed for at least 30 minutes after vaccination so that clinic personnel can observe and document any potential adverse reactions to the vaccine. Report of vaccine-related local (redness, swelling, pain/tenderness, itching) and systemic (fever, vomiting, poor appetite, irritability and decreased activity) adverse events will be solicited using diary card in the 7 days after vaccination.

  5. Number of participants with vaccine-related adverse events after varicella vaccination [ Time Frame: 18 months of age ]
    Participants will be observed for at least 30 minutes after vaccination so that clinic personnel can observe and document any potential adverse reactions to the vaccine. Report of vaccine-related local (redness, swelling, pain/tenderness, itching) and systemic (fever, vomiting, poor appetite, irritability and decreased activity) adverse events will be solicited using diary card in the 7 days after vaccination.

  6. Number of participants with vaccine-related adverse events after hepatitis-A vaccination [ Time Frame: 18 months of age ]
    Participants will be observed for at least 30 minutes after vaccination so that clinic personnel can observe and document any potential adverse reactions to the vaccine. Report of vaccine-related local (redness, swelling, pain/tenderness, itching) and systemic (fever, vomiting, poor appetite, irritability and decreased activity) adverse events will be solicited using diary card in the 7 days after vaccination.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Weeks to 19 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Aged ≤18 weeks;
  2. Parent/guardian able to provide informed consent;
  3. Available for the duration of the study;
  4. 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;
  5. Birth weight >2499g AND weight of >3.5 kg at time of proposed enrolment;
  6. 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:

  1. Significant major congenital abnormalities;
  2. Received measles vaccination, varicella vaccination or hepatitis-A vaccination since birth;
  3. Previous hospitalization for respiratory illness following discharge from hospital at birth;
  4. Known allergy to vaccine components;
  5. Febrile illness (axillary temperature ≥37.8°C) at time of screening;
  6. Known or suspected immunodeficiency condition other than HIV;
  7. Planning to relocate outside of the study area during the study period;
  8. 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;
  9. History of confirmed measles, varicella or hepatitis-A disease since birth.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03330171


Contacts
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Contact: Shabir A Madhi, MD, PhD +27119834283 madhis@rmpru.co.za
Contact: Eleonora A Mutsaerts, MD +27119834283 mutsaertse@rmpru.co.za

Locations
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South Africa
Chris Hani Baragwanath Academic Hospital; Nrf/Dst Vpd Rmpru Recruiting
Soweto, Gauteng, South Africa, 2013
Contact: Shabir A Madhi, MD, PhD    +27119834283    madhis@rmpru.co.za   
Contact: Eleonora A Mutsaerts, MD    +27119834283    mutsaertse@rmpru.co.za   
Sub-Investigator: Marta C Nunes, PhD         
Sponsors and Collaborators
University of Witwatersrand, South Africa
Investigators
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Principal Investigator: Shabir A Madhi, MD, PhD University of Witwatersrand, South Africa

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shabir Madhi, Investigator, University of Witwatersrand, South Africa
ClinicalTrials.gov Identifier: NCT03330171     History of Changes
Other Study ID Numbers: MV/VV/Hep-AV
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data will be made publicly available, within one year of completion of the study to any investigator or RMPRU nominated partners, who wish to use the data to address any specific questions not directly addressed under the study objectives and which the data would lend itself to.
Time Frame: The data will be made publicly available, within one year of completion of the study.
Access Criteria: Data will be made available to investigators or RMPRU nominated partners, who wish to use the data to address any specific questions not directly addressed under the study objectives and which the data would lend itself to.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shabir Madhi, University of Witwatersrand, South Africa:
Immunogenicity
Safety
Vaccine
Additional relevant MeSH terms:
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Hepatitis A
Measles
Chickenpox
Herpes Zoster
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs