MeaslesPhase 4MV/VV/Hep-AVNCT03330171

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

A Phase 4 study testing Measles vaccine, Hepatitis-A vaccine and Varicella vaccine in people with Measles and Varicella, run by University of Witwatersrand, South Africa at 1 site in South Africa.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 weeks to 19 monthsHealthy volunteers can take part
Conditions the study is for: Measles, Varicella, Hepatitis A
What is being tested?: Measles vaccine, Hepatitis-A vaccine and Varicella vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 278 participants
Where: 1 siteSouth Africa
Study dates: 10 Apr 2017to 1 Dec 2022
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 weeks to 19 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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.

Who cannot join

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;

Show all 9Show fewer

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.

Trial locations and contacts

1 site in 1 country.

South Africa1 site

Chris Hani Baragwanath Academic Hospital; Nrf/Dst Vpd Rmpru
Soweto, Gauteng, 2013

Other trials in South Africa

About this study

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

Read the 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
Being tested: Measles vaccine, Hepatitis-A vaccine, Varicella vaccine
Keywords: Immunogenicity, Safety, Vaccine
Medical subject headings: Measles, Chickenpox, Hepatitis A

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Measles vaccineBiological
Also called Measles vaccine (MeasBio) 0.5 mL
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.
Hepatitis-A vaccineBiological
Also called Hepatitis-A vaccine (Varilrix) 0.5 mL
Half of the participants (n=135) will receive hepatitis-A vaccine at 18 months of age.
Varicella vaccineBiological
Also called Varicella vaccine (Avaxim Paediatric) 0.5 mL
Half of the participants (n=135) will receive varicella vaccine at 18 months of age.

Study groups in NCT03330171
Study group	Role	What they receive
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. Receives: Biological: Measles vaccine; Biological: Hepatitis-A vaccine; Biological: 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. Receives: Biological: Measles vaccine; Biological: Hepatitis-A vaccine; Biological: Varicella vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured as seroprotection rate one month post varicella immunization in HIV-exposed (HEU, HIV-infected) and HIV-unexposed South African children.
Measured: 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
Measured as seroprotection rate one month post hepatitis-A immunization in HIV-exposed (HEU, HIV-infected) and HIV-unexposed South African children.
Measured: 19 months of age (one month post vaccination)
Number of participants with vaccine-related adverse events after primary measles vaccination
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.
Measured: 6 months of age
Number of participants with vaccine-related adverse events after booster measles vaccination
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.
Measured: 12 months of age
Number of participants with vaccine-related adverse events after varicella vaccination
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.
Measured: 18 months of age
Number of participants with vaccine-related adverse events after hepatitis-A vaccination
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.
Measured: 18 months of age
Persistence of immunogenicity
Antibody concentrations and number of participants with seroprotective antibody levels to measles, varicella and hepatitis-A vaccination
Measured: 3, 4 and 5 years of age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Apr 20171 Dec 2022

First posted6 Nov 2017
Study start10 Apr 2017
Primary completion26 Feb 2019
Study completion1 Dec 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for MeaslesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
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)
Enrolment: 278 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03330171
Sponsor's protocol ID: MV/VV/Hep-AV
Acronym: MV/VV/Hep-AV
Status last verified: Mar 2020
First submitted: 12 Oct 2017
Last updated: 17 Mar 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Currently no plan to share IPD.

Publications

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.
PubMed 38637212
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.
PubMed 32307279
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.
PubMed 31282539

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Immunogenicity of Measles Vaccine, Varicella Vaccine and Hepatitis-A Vaccine in HIV-exposed and HIV-unexposed South African Children
ClinicalTrials.gov ID: NCT03330171
Acronym / sponsor ID: MV/VV/Hep-AV / MV/VV/Hep-AV
Conditions: Measles, Varicella, Hepatitis A
Keywords: Immunogenicity, Safety, Vaccine
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 278 participants (actual)
Lead sponsor: University of Witwatersrand, South AfricaUniversity, hospital or other
Study start: 10 Apr 2017 (actual)
Primary completion: 26 Feb 2019 (actual)
Study completion: 1 Dec 2022 (estimated)
First posted: 6 Nov 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
HIV-unexposed children	Other	Biological: Measles vaccine, Biological: Hepatitis-A vaccine, Biological: Varicella vaccineHIV-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.
HIV-exposed children	Other	Biological: Measles vaccine, Biological: Hepatitis-A vaccine, Biological: Varicella vaccineA 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.

Who may qualify

Ages: 18 weeks to 19 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (9 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Measles vaccineAlso: Measles vaccine (MeasBio) 0.5 mLAll 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	HIV-exposed children, HIV-unexposed children
Hepatitis-A vaccineAlso: Hepatitis-A vaccine (Varilrix) 0.5 mLHalf of the participants (n=135) will receive hepatitis-A vaccine at 18 months of age.	Biological	HIV-exposed children, HIV-unexposed children
Varicella vaccineAlso: Varicella vaccine (Avaxim Paediatric) 0.5 mLHalf of the participants (n=135) will receive varicella vaccine at 18 months of age.	Biological	HIV-exposed children, HIV-unexposed children

Primary outcome

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.

7 secondary outcomes

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)
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)
Number of participants with vaccine-related adverse events after primary measles vaccination
Time frame: 6 months of age
Number of participants with vaccine-related adverse events after booster measles vaccination
Time frame: 12 months of age
Number of participants with vaccine-related adverse events after varicella vaccination
Time frame: 18 months of age
Number of participants with vaccine-related adverse events after hepatitis-A vaccination
Time frame: 18 months of age
Persistence of immunogenicity
Time frame: 3, 4 and 5 years of age

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
Derived from this study: PubMed 38637212Mutsaerts 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.
Derived from this study: PubMed 32307279Mutsaerts 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.
Derived from this study: PubMed 31282539Mutsaerts 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.
Individual participant dataSharing planned: No. Currently no plan to share IPD.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shabir A Madhi, MD, PhD principal investigator

University of Witwatersrand, South Africa

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Measles vaccine, Hepatitis-A vaccine and Varicella vaccine in people with Measles and Varicella, run by University of Witwatersrand, South Africa at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03330171, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.