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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04351685
Recruitment Status : Not yet recruiting
First Posted : April 17, 2020
Last Update Posted : April 17, 2020
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
Estimated Study Start Date : June 10, 2020
Estimated Primary Completion Date : July 10, 2023
Estimated Study Completion Date : June 10, 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.

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. Any malignant condition.

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
Lambaréné, Gabon
Contact: Prof Ayola Adegnika    +24106244472      
Kenya
Kenya Medical Research Institute / Center for Respiratory Disease Research
Nairobi, Kenya
Contact: Dr Videlis Nduba    +254724522474      
Kenya Medical Research Institute - Center for Respiratory Disease Research
Siaya, Kenya, 144
Contact: Dr Videlis Nduba    +254 724 522474      
South Africa
Family Clinical Research Unit
Cape Town, South Africa, 7505
Contact: Prof Mark Frederic Cotton    +27219384963      
MeCRU clinical research Unit
Pretoria North, South Africa, 0204
Contact: Dr. Matsontso Peter Mathebula    +270125215714      
Respiratory and Meningeal Pathogens Research Unit
Soweto, South Africa, 2013
Contact: Prof Shabir Ahmed Madhi, MD    +27119834283      
University of Cape Town South African Tuberculosis Vaccine Initiative
Worcester, South Africa, 6850
Contact: Dr Angelique Kany Kany Luabeya    +27233465400      
Tanzania
Ifakara Health Institute
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
Entebbe, Uganda
Contact: Dr Anne Wajja    +256778103960      
Makerere University/CISMAC
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: April 17, 2020
Last Verified: April 2020
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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Infection
Communicable Diseases
Tuberculosis
Mycobacterium Infections
Latent Tuberculosis
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections