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TuberculosisPhase 2NCT02391415

Study to Evaluate the Safety and Immunogenicity of VPM1002 in Comparison With BCG in HIV-exposed/-Unexposed Newborn Infants in South Africa

A Phase 2 study testing VPM1002, BCG and VPM1002(Hyg+) in people with Tuberculosis, run by Serum Institute of India Pvt. Ltd. at 4 sites in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Goal of Serum Institute of India Limited (SIIL) is the development of a recombinant urease C-deficient listeriolysin expressing BCG vaccine strain (VPM1002) as a safe, well tolerated and efficacious vaccine against tuberculosis (TB) for residents in endemic areas and persons at risk in non-endemic areas. Read more about this study

Who is it for?
Ages Up to 12 daysHealthy volunteers can take part
Conditions the study is for
Tuberculosis
What is being tested?
VPM1002, BCG and VPM1002(Hyg+)
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
416 participants
Where
4 sitesSouth Africa
Study dates
Jun 2015to Nov 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 12 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Maternal:
  • The infant's mother must be aged 18 years or older at screening.
  • The infant's mother must be able and willing to comply with the study protocol, available and willing to allow her child to complete all the study assessments and must have signed an Informed Consent form that has been approved by all relevant Ethics Committee/s.
  • The infant's mother must not have any symptoms or signs of active TB as indicated by history of cough for more than two weeks, fever, weight loss, breathlessness, chest pain, blood in sputum, night sweats and loss of appetite
  • The infant's mother should not be planning to relocate from the research site area and should be reachable by phone during the whole study period i.e. for the 12 months on-study period as well as the 24 month structured medical surveillance period.
  • For HIV-unexposed group: The infant's mother must test negative for HIV-1 (ELISA 4th generation) within the period from 2 weeks prior to the infant's birth to vaccination of the infant with the investigational product.
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  • For the HIV-exposed group: The infant's mother must test positive for HIV-1 (ELISA 4th generation) within the period from 2 weeks prior to the infant's birth to vaccination of the infant with the investigational product. The infant's mother must have enrolled for standard antiretroviral therapy (ART) at least 3 months before the participating infant's birth and must have a viral load at screening below 1000 copies/ml. The use of ART, including combination antiretroviral therapy (cART) and preventive mother to child transmission (PMTCT) must be documented. CD4+ T cell count and HIV viral load must be documented.
  • The infant's mother must test negative for Hepatitis B and syphilis serology at screening.
  • The infant's mother should have no history or evidence of diabetes mellitus.
  • No participation of the infant's mother in a clinical trial within 3 months prior to the birth of the participating infant. In addition, if breast-feeding, no participation in another clinical trial during the 12 months of the current study.
  • The infant's mother must have no known history of immunodeficiency, except for HIV.
  • Infant:
  • Healthy male or female newborn infants aged 0 to 12 days.
  • Infants must have a birth weight of 2500 - 4200 g and an Apgar score of > 7 at 5 minutes or earlier.
  • No eczema or other significant skin lesion or infection at the intended injection site.
  • No routine BCG vaccination administered (as per vaccination record)
  • Infants must receive Oral Polio Vaccine as part of the routine South African Expanded Programme on Immunisation (EPI) Childhood Immunisation schedule, and must adhere to the subsequent EPI schedule for the entire study period, except for the BCG vaccination at birth.
  • No participation of the infant in another clinical trial before study vaccination and during the 12 months of the current study.

Who cannot join

  • Maternal:
  • Known presence of any person in the household of the mother and newborn infant, or any recent visitor to the household with recently diagnosed, active tuberculosis disease (within last 3 months).
  • Treatment of the mother with blood products in the 6 months prior to or during the birth of the participating infant.
  • For the HIV-unexposed group: Positive test for HIV-1 either during the current pregnancy or at screening.
  • For the HIV-exposed group: Negative test for HIV-1 either during the current pregnancy or at screening.
  • Presence of signs or symptoms of any reported acute infectious disease at the time of screening.
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  • Any reported or suspected substance abuse.
  • Infant:
  • History or evidence of any systemic disease on physical examination or any acute, chronic or intercurrent illness that, in the opinion of the investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine.
  • Note: Neonatal jaundice not considered clinically significant by the investigator is not an exclusion.
  • Fever within the period post birth and prior to dosing. For the purposes of this protocol, fever in the infant will be defined as an axillary body temperature > 38.0°C measured by digital thermometer on at least 2 occasions not less than 6 hours apart.
  • Hypothermia within the period post birth and prior to dosing. For the purposes of this protocol, hypothermia in the infant will be defined as an axillary body temperature < 36.0°C measured by digital thermometer on at least 2 occasions not less than 6 hours apart.
  • Clinically suspected newborn sepsis.
  • Any malignant condition.
  • Any severe congenital malformation.
  • Concomitant treatment with medication that may significantly affect immune function (e.g. systemic corticoids, immunosuppressive drugs) before study vaccination. Antibiotics given before study vaccination would further constitute exclusion.
  • Treatment of the infant with blood products.

Trial locations and contacts

4 sites in 1 country.

South Africa4 sites

  • Children's Infectious Diseases Clinical Research Unit, Tygerberg Hospital

    Cape Town

  • Desmond Tutu TB Centre

    Cape Town

  • South African Tuberculosis Vaccine Initiative

    Cape Town

  • The Respiratory and Meningeal Pathogens Reserach Unit

    Johannesburg

Other trials in South Africa

About this study

Official title: Phase II Double-blind, Randomized, Controlled Study to Evaluate Safety and Immunogenicity of VPM1002 Compared With BCG in HIV-exposed and HIV-unexposed, BCG-naive Newborn Infants

Goal of Serum Institute of India Limited (SIIL) is the development of a recombinant urease C-deficient listeriolysin expressing BCG vaccine strain (VPM1002) as a safe, well tolerated and efficacious vaccine against tuberculosis (TB) for residents in endemic areas and persons at risk in non-endemic areas. The new vaccine should be at least as potent as the current strain and should be safer than BCG.

The preceding phase-IIa trial was the first investigation of VPM1002 in newborn infants in a high burden setting in South Africa. The vaccination of HIV-unexposed infants with VPM1002 indicated again safety, tolerability and immunogenicity sufficient to proceed in HIV-exposed infants.

The current study is a multiple site trial in South Africa to evaluate safety and immunogenicity in HIV-unexposed and -exposed newborn infants.

Conditions
Tuberculosis
Being tested
VPM1002, BCG, VPM1002(Hyg+)
Medical subject headings
Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VPM1002Biological

    Also called recombinant BCG for TB

    Tuberculosis vaccine

  • BCGBiological

    commercially available live vaccine BCG

  • VPM1002(Hyg+)Biological

    Also called recombinant BCG for TB

    Tuberculosis vaccine

Study groups in NCT02391415
Study groupRoleWhat they receive
HIV-unexposed infants VPM1002ExperimentalHIV-unexposed infants vaccinated with VPM1002
Receives: Biological: VPM1002
HIV-unexposed infants BCGActive comparatorHIV-unexposed infants vaccinated with BCG
Receives: Biological: BCG
HIV-unexposed infants VPM1002(Hyg+)ExperimentalHIV-unexposed infants vaccinated with VPM1002(Hyg+)
Receives: Biological: VPM1002(Hyg+)
HIV-exposed infants BCGActive comparatorHIV-exposed infants vaccinated with BCG
Receives: Biological: BCG
HIV-exposed infants VPM1002ExperimentalHIV-exposed infants vaccinated with VPM1002
Receives: Biological: VPM1002

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The difference between the VPM1002 and BCG vaccination groups in the incidence of grade 3 and 4 adverse drug reactions and IMP-related ipsilateral or generalised lymphadenopathy of 10mm or greater (diameter).

    Measured: up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionNov 2017
  4. Study completionNov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
416 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02391415
Sponsor's protocol ID
VPM1002-ZA-2.13TB
Other IDs
DOH-27-1114-4798
Status last verified
Apr 2018
First submitted
5 Mar 2015
Last updated
18 Apr 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Cotton MF, Madhi SA, Luabeya AK, Tameris M, Hesseling AC, Shenje J, Schoeman E, Hatherill M, Desai S, Kapse D, Bruckner S, Koen A, Jose L, Moultrie A, Bhikha S, Walzl G, Gutschmidt A, Kotze LA, Allies DL, Loxton AG, Shaligram U, Abraham M, Johnstone H, Grode L, Kaufmann SHE, Kulkarni PS. Safety and immunogenicity of VPM1002 versus BCG in South African newborn babies: a randomised, phase 2 non-inferiority double-blind controlled trial. Lancet Infect Dis. 2022 Oct;22(10):1472-1483. doi: 10.1016/S1473-3099(22)00222-5. Epub 2022 Jun 27.

    PubMed 35772447

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VPM1002, BCG and VPM1002(Hyg+) in people with Tuberculosis, run by Serum Institute of India Pvt. Ltd. at 4 sites in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The difference between the VPM1002 and BCG vaccination groups in the incidence of grade 3 and 4 adverse drug reactions and IMP-related ipsilateral or generalised lymphadenopathy of 10mm or greater (diameter). (time frame: up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02391415, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.

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