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

Mycobacterium Tuberculosis Infection Clinical Trial

— VPM1002  

Official title:

A Multicenter, Phase III, Double-blind, Randomized, Active-controlled Study to Evaluate the Efficacy and Safety of VPM1002 in Comparison to BCG in Prevention of Mycobacterium Tuberculosis Infection in Newborn Infants

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04351685
• Other study ID #: VPM1002-MN-3.05TB
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 9, 2020
• Est. completion date: November 30, 2025

Study information

• Verified date: December 2022
• Source: Serum Institute of India Pvt. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6940
• Est. completion date: November 30, 2025
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Days to 14 Days

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Latent Tuberculosis
• Mycobacterium Infections
• Mycobacterium Tuberculosis Infection
• Tuberculosis

Intervention

Biological:
• 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
• 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

Locations

Country	Name	City	State
Gabon	Centre de Recherches Médicales de Lambaréné	Lambaréné
Kenya	Kenya Medical Research Institute / Center for Respiratory Disease Research	Nairobi
Kenya	Kenya Medical Research Institute - Center for Respiratory Disease Research	Siaya
South Africa	Family Center for Research with Ubuntu	Cape Town
South Africa	Empilweni Services and Research Unit (ESRU)	Johannesburg	Coronation Ville
South Africa	Mecru Clinical Research Unit	Medunsa
South Africa	Respiratory and Meningeal Pathogens Research Unit	Soweto
South Africa	South African Tuberculosis Vaccine Initiative	Worcester
Tanzania	Ifakara Health Institute	Dar Es Salaam
Tanzania	The national institute for Medical Research (NIMR) - Mbeya Medical Research Center (MMRC)	Mbeya
Uganda	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

Sponsors (2)

Lead Sponsor	Collaborator
Serum Institute of India Pvt. Ltd.	Vakzine Projekt Management GmbH

Countries where clinical trial is conducted

Gabon,  Kenya,  South Africa,  Tanzania,  Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incident cases of QFT conversion, indicating Mtb infection		Minimum of 12 months and maximum of 36 months
Secondary	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