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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04351685
Recruitment Status : Active, not recruiting
First Posted : April 17, 2020
Last Update Posted : December 20, 2022
Sponsor:
Collaborator:
Vakzine Projekt Management GmbH
Information provided by (Responsible Party):
Serum Institute of India Pvt. Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Mycobacterium Tuberculosis Infection Biological: VPM1002 Biological: BCG SII Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6940 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The study is designed as a double-blind study.
Primary Purpose: Prevention
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
Actual Study Start Date : November 9, 2020
Estimated Primary Completion Date : August 30, 2023
Estimated Study Completion Date : November 30, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: VPM1002

Total 3470 subjects will be enrolled in VPM1002 arm.

Single dose of VPM1002 will be administered.

 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
Active Comparator: BCG SII

Total 3470 subjects will be enrolled in BCG SII arm.

Single dose of BCG SII will be administered.

 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


Outcome Measures
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Primary Outcome Measures :
  1. Incident cases of QFT conversion, indicating Mtb infection [ Time Frame: Minimum of 12 months and maximum of 36 months ]

Secondary Outcome Measures :
  1. The rate of TB disease in children receiving VPM1002 compared to BCG SII. Incident cases of sustained QFT conversion, indicating sustained Mtb infection. [ Time Frame: 36 Months ]

Eligibility Criteria
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Ages Eligible for Study:   0 Days to 14 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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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): NCT04351685


Locations
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Gabon
Centre de Recherches Médicales de Lambaréné
Lambaréné, Gabon
Kenya
Kenya Medical Research Institute / Center for Respiratory Disease Research
Nairobi, Kenya, 47855-00100
Kenya Medical Research Institute - Center for Respiratory Disease Research
Siaya, Kenya, 144
South Africa
Empilweni Services and Research Unit (ESRU)
Johannesburg, Coronation Ville, South Africa, 2093
Family Center for Research with Ubuntu
Cape Town, South Africa, 7505
Mecru Clinical Research Unit
Medunsa, South Africa, 0204
Respiratory and Meningeal Pathogens Research Unit
Soweto, South Africa, 2013
South African Tuberculosis Vaccine Initiative
Worcester, South Africa, 6850
Tanzania
Ifakara Health Institute
Dar Es Salaam, Tanzania, 61665
The national institute for Medical Research (NIMR) - Mbeya Medical Research Center (MMRC)
Mbeya, Tanzania, 2410
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, Uganda, 7062
Sponsors and Collaborators
Serum Institute of India Pvt. Ltd.
Vakzine Projekt Management GmbH
Investigators
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Study Director: Dr Prasad Kulkarni, MD Serum Institute of India Pvt. Ltd.
More Information
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Responsible Party: Serum Institute of India Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT04351685    
Other Study ID Numbers: VPM1002-MN-3.05TB
First Posted: April 17, 2020    Key Record Dates
Last Update Posted: December 20, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Serum Institute of India Pvt. Ltd.:
Bacterial and fungal diseases
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Tuberculosis
Mycobacterium Infections
Latent Tuberculosis
Disease Attributes
 Pathologic Processes
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Latent Infection