Evaluation of Efficacy and Safety of VPM1002 in Comparison to BCG in Prevention of Tb Infection in Infants

NCT ID: NCT04351685

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 6940 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-09
• Study Completion Date: 2024-10-30

Brief Summary

The trial is designed as a phase III, double-blind, multicenter, randomized, single administration, active-controlled, parallel-group design with two groups of newborn infants receiving either VPM1002 or BCG SII (1:1 allocation) to assess the efficacy, safety and immunogenicity of VPM1002 against Mtb infection.

Detailed Description

The trial is designed as a phase III, double-blind, multicenter, randomized, single administration, active-controlled, parallel-group design with two groups of newborn infants receiving either VPM1002 or BCG SII (1:1 allocation) to assess the efficacy, safety and immunogenicity of VPM1002 against Mtb infection.

Healthy male or female newborn infants will be centrally randomized to receive the allocated vaccine, stratified by the HIV status of the mother. Single dose of VPM1002 or BCG SII will be administered (within 14 days of birth) strictly intradermally.

Conditions

Mycobacterium Tuberculosis Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

VPM1002

Total 3470 subjects will be enrolled in VPM1002 arm.

Single dose of VPM1002 will be administered.

Group Type: EXPERIMENTAL

VPM1002

Intervention Type: BIOLOGICAL

The active ingredient of the recombinant BCG vaccine, VPM1002 is Mycobacterium bovis A dose of 0.05 ml will be administered intradermally.

Manufactured by the Serum Institute of India Pvt. Ltd., India

Diluent: 1 ml of Water for injection/vial

BCG SII

Total 3470 subjects will be enrolled in BCG SII arm.

Single dose of BCG SII will be administered.

Group Type: ACTIVE_COMPARATOR

BCG SII

Intervention Type: BIOLOGICAL

Commercially available BCG vaccine from Serum Institute of India Pvt. Ltd. A dose of 0.05 ml will be administered intradermally.

Manufactured by the Serum Institute of India Pvt. Ltd., India

Diluent: 1 ml of Sodium Chloride for injection/vial Injection

Interventions

VPM1002

The active ingredient of the recombinant BCG vaccine, VPM1002 is Mycobacterium bovis A dose of 0.05 ml will be administered intradermally.

Manufactured by the Serum Institute of India Pvt. Ltd., India

Diluent: 1 ml of Water for injection/vial

Intervention Type: BIOLOGICAL

BCG SII

Commercially available BCG vaccine from Serum Institute of India Pvt. Ltd. A dose of 0.05 ml will be administered intradermally.

Manufactured by the Serum Institute of India Pvt. Ltd., India

Diluent: 1 ml of Sodium Chloride for injection/vial Injection

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

A Maternal

1. Age: 18 years or older at screening.

2. Willing to comply with the trial protocol, available and willing to allow her child to complete all the trial assessments and must have signed an Informed Consent form that has been approved by respective Site Ethics Committee.

3. No symptoms or signs of active TB at the time of participant's enrolment.

4. Parent / guardian who intends to remain in the trial area with the child should be reachable by phone during the trial period.

5. For HIV-unexposed group: Test negative for HIV within two months prior to the newborn infant's vaccination. Test result must be documented, in absence of which a HIV test must be performed at the infant screening visit.

6. For the HIV-exposed group: Test positive for HIV and test result must be documented. If documentation is missing, a HIV test must be performed at the screening visit. The newborn infant's mother must have enrolled for standard antiretroviral therapy (ART) at least 2 months before the participant's birth

7. No participation in an interventional clinical trial within 3 months prior to the participant's birth. In addition, if mother is breast-feeding then she must not participate in another clinical trial during the current trial period while breastfeeding.

B Infant

1. Healthy male or female newborn infant.

2. Birth weight of at least 2,300 g.

3. Test negative for HIV by PCR at screening if born to an HIV-infected mother.

4. No participation in an interventional clinical trial prior to enrolment. Participant should not take part in another clinical trial for the duration of the current trial period.

Exclusion Criteria

A Maternal

1. Any reported or suspected substance abuse during pregnancy.

2. House-hold contact with active TB (defined as residing in the same house as an individual with active TB) within the 3 months prior to enrolment.

B Infant

1. Fever at the time of enrolment.

2. Eczema or other significant skin lesion or infection at the site/s of injection as per protocol.

3. Receipt of routine BCG vaccine (as per vaccination record).

4. Clinically suspected sepsis.

5. Clinically suspected sepsis.

6. Any malignant condition.

7. Any clinically significant severe congenital malformation, which may interfere with the evaluation of the safety, efficacy or immunogenicity of the vaccine.

8. Concomitant treatment with medication that may significantly affect immune function (e.g. systemic corticoids, immunosuppressive drugs) before trial vaccination. (Note: Routine medication given at birth such as topical antibiotics for eye care and vitamins A and K are permitted. In HIV-exposed newborn infants prevention of mother-to-child transmission (PMTCT) based on standard of care is allowed, but must be documented.)

9. Receipt of blood products or immunoglobulin before trial vaccination.

• Minimum Eligible Age: 0 Days
• Maximum Eligible Age: 14 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Serum Life Science Europe GmbH

INDUSTRY

Sponsor Role: collaborator

Serum Institute of India Pvt. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr Prasad Kulkarni, MD

Role: STUDY_DIRECTOR

Serum Institute of India Pvt. Ltd.

Locations

Centre de Recherches Médicales de Lambaréné

Lambaréné, , Gabon

Kenya Medical Research Institute / Center for Respiratory Disease Research

Nairobi, , Kenya

Kenya Medical Research Institute - Center for Respiratory Disease Research

Siaya, , Kenya

Empilweni Services and Research Unit (ESRU)

Johannesburg, Coronation Ville, South Africa

Family Center for Research with Ubuntu

Cape Town, , South Africa

Mecru Clinical Research Unit

Medunsa, , South Africa

Respiratory and Meningeal Pathogens Research Unit

Soweto, , South Africa

South African Tuberculosis Vaccine Initiative

Worcester, , South Africa

The national institute for Medical Research (NIMR) - Mbeya Medical Research Center (MMRC)

Mbeya, Mbeya, Tanzania

Ifakara Health Institute

Dar es Salaam, , Tanzania

Medical Research Council / Uganda Virus Research Institute and London School of Hygiene and Tropical Medicines (MRC/UVRI and LSHTM) Uganda Research Unit

Entebbe, , Uganda

Makerere University/CISMAC

Kampala, , Uganda

Countries

Gabon; Kenya; South Africa; Tanzania; Uganda

References

Giersing B, Mo AX, Hwang A, Baqar S, Earle K, Ford A, Deal C, Dull P, Friede M, Hall BF. Meeting summary: Global vaccine and immunization research forum, 2023. Vaccine. 2025 Feb 6;46:126686. doi: 10.1016/j.vaccine.2024.126686. Epub 2025 Jan 5.

Reference Type: DERIVED

PMID: 39752894 (View on PubMed)

Other Identifiers

VPM1002-MN-3.05TB

Identifier Type: -

Identifier Source: org_study_id