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

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ClinicalTrials.gov Identifier: NCT04351685
Recruitment Status : Recruiting
First Posted : April 17, 2020
Last Update Posted : September 29, 2021
Sponsor:
Collaborator:
Vakzine Projekt Management GmbH
Information provided by (Responsible Party):
Serum Institute of India Pvt. Ltd.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 30, 2022
Estimated Study Completion Date : November 30, 2025

Resource links provided by the National Library of Medicine


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





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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up 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.

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


Contacts
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Contact: Dr Prasad Kulkarni, MD + 91-20-26602384 drpsk@seruminstitute.com
Contact: Dr Sajjad Desai, MD + 91-20-26602781 sajjad.desai@seruminstitute.com

Locations
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Gabon
Centre de Recherches Médicales de Lambaréné Recruiting
Lambaréné, Gabon
Contact: Prof Ayola Adegnika    +24106244472      
Kenya
Kenya Medical Research Institute / Center for Respiratory Disease Research Recruiting
Nairobi, Kenya, 47855-00100
Contact: Dr Videlis Nduba    +254724522474      
Kenya Medical Research Institute - Center for Respiratory Disease Research Recruiting
Siaya, Kenya, 144
Contact: Dr Videlis Nduba    +254 724 522474      
South Africa
Empilweni Services and Research Unit (ESRU) Recruiting
Johannesburg, Coronation Ville, South Africa, 2093
Contact: Prof Shabir Ahmed Madhi    +27119834283      
Contact: Dr. Renate Strehlau    +27114709000      
Family Center for Research with Ubuntu Recruiting
Cape Town, South Africa, 7505
Contact: Prof Mark Frederic Cotton    +27219384963      
Mecru Clinical Research Unit Recruiting
Medunsa, South Africa, 0204
Contact: Dr. Matsontso Peter Mathebula    +270125215714      
Respiratory and Meningeal Pathogens Research Unit Not yet recruiting
Soweto, South Africa, 2013
Contact: Prof Shabir Ahmed Madhi, MD    +27119834283      
South African Tuberculosis Vaccine Initiative Recruiting
Worcester, South Africa, 6850
Contact: Dr Angelique Kany Kany Luabeya    +27233465400      
Tanzania
Ifakara Health Institute Recruiting
Dar Es Salaam, Tanzania, 61665
Contact: Dr Francis Mhimbira    +225754291657      
Uganda
Medical Research Council / Uganda Virus Research Institute and London School of Hygiene and Tropical Medicines (MRC/UVRI and LSHTM) Uganda Research Unit Not yet recruiting
Entebbe, Uganda
Contact: Dr Anne Wajja    +256778103960      
Makerere University/CISMAC Not yet recruiting
Kampala, Uganda, 7062
Contact: Dr Victoria Nankabirwa    +256755757460      
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.
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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: September 29, 2021
Last Verified: September 2021
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