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

NCT04351685 | Completed Phase 3 DMC

• 1 other identifier: VPM1002-MN-3.05TB
• Study Type: interventional
• Target: 6,940
• Locations: 5 countries
• Sites: 12

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.

Conditions

Mycobacterium Tuberculosis Infection

Keywords

Bacterial and fungal diseases

Outcome Measures

Primary Outcomes (1)

• Incident cases of QFT conversion, indicating Mtb infection

  Minimum of 12 months and maximum of 36 months

Secondary Outcomes (1)

• The rate of TB disease in children receiving VPM1002 compared to BCG SII. Incident cases of sustained QFT conversion, indicating sustained Mtb infection.

  36 Months

Study Arms (2)

VPM1002

EXPERIMENTAL

Total 3470 subjects will be enrolled in VPM1002 arm. Single dose of VPM1002 will be administered.

Biological: VPM1002

BCG SII

ACTIVE COMPARATOR

Total 3470 subjects will be enrolled in BCG SII arm. Single dose of BCG SII will be administered.

Biological: BCG SII

Interventions

VPM1002 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

VPM1002

BCG SII 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

BCG SII

Eligibility Criteria

• Age: 0 Days - 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• A Maternal
• Age: 18 years or older at screening.
• 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.
• No symptoms or signs of active TB at the time of participant's enrolment.
• Parent / guardian who intends to remain in the trial area with the child should be reachable by phone during the trial period.
• 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.
• 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
• 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
• Healthy male or female newborn infant.
• Birth weight of at least 2,300 g.
• Test negative for HIV by PCR at screening if born to an HIV-infected mother.
• 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.

You may not qualify if:

• A Maternal
• Any reported or suspected substance abuse during pregnancy.
• 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
• Fever at the time of enrolment.
• Eczema or other significant skin lesion or infection at the site/s of injection as per protocol.
• Receipt of routine BCG vaccine (as per vaccination record).
• Clinically suspected sepsis.
• Clinically suspected sepsis.
• Any malignant condition.
• Any clinically significant severe congenital malformation, which may interfere with the evaluation of the safety, efficacy or immunogenicity of the vaccine.
• 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.)
• Receipt of blood products or immunoglobulin before trial vaccination.

Sponsors & Collaborators

• Serum Institute of India Pvt. Ltd.: lead
• Serum Life Science Europe GmbH: collaborator

Study Sites (12)

Centre de Recherches Médicales de Lambaréné

Lambaréné, Gabon

Location

Kenya Medical Research Institute / Center for Respiratory Disease Research

Nairobi, 47855-00100, Kenya

Location

Kenya Medical Research Institute - Center for Respiratory Disease Research

Siaya, 144, Kenya

Location

Empilweni Services and Research Unit (ESRU)

Johannesburg, Coronation Ville, 2093, South Africa

Location

Family Center for Research with Ubuntu

Cape Town, 7505, South Africa

Location

Mecru Clinical Research Unit

Medunsa, 0204, South Africa

Location

Respiratory and Meningeal Pathogens Research Unit

Soweto, 2013, South Africa

Location

South African Tuberculosis Vaccine Initiative

Worcester, 6850, South Africa

Location

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

Mbeya, Mbeya, 2410, Tanzania

Location

Ifakara Health Institute

Dar es Salaam, 61665, Tanzania

Location

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

Entebbe, Uganda

Location

Makerere University/CISMAC

Kampala, 7062, Uganda

Location

Related Publications (1)

• 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.

  PMID: 39752894 DERIVED

MeSH Terms

Conditions

Tuberculosis; Mycoses

Interventions

VPM1002 recombinant BCG vaccine

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Dr Prasad Kulkarni, MD

  Serum Institute of India Pvt. Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study is designed as a double-blind study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 17, 2020
• Study Start: November 9, 2020
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (5); KE (2); TA (2); GA (1); UG (2)