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TuberculosisPhase 2NCT01479972

Study to Evaluate Safety and Immunogenicity of VPM1002 in Comparison With BCG in Newborn Infants in South Africa

A Phase 2 study testing VPM1002 and BCG in people with Tuberculosis, run by Serum Life Science Europe GmbH at 1 site in South Africa.

Completed

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

Official record
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Trial summary

Goal of VPM 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 8 daysHealthy volunteers can take part
Conditions the study is for
Tuberculosis
What is being tested?
VPM1002 and BCG
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteSouth Africa
Study dates
Nov 2011to Nov 2012
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 8 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 the time of 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 either active TB or latent tuberculosis infection 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, and/or
  • Mantoux Tuberculin PPD skin test greater than or equal to 10 mm
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  • 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 6 month on-study period as well as the 30 month structured medical surveillance period.
  • 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.
  • 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 6 months of the current study.
  • The infant's mother must have no known history of immunodeficiency.
  • Infant:
  • Healthy full-term male or female newborn infants aged 0 to 8 days.
  • Infants must have a birth weight of 3000 - 4000 g and an Apgar score of > 9 at 5 minutes.
  • 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 have received 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 6 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 visitor to the household with reported active tuberculosis disease.
  • Treatment of the mother with blood products in the 6 months prior to or during the birth of the participating infant.
  • Positive test for HIV-1 either during the current pregnancy or at screening.
  • Positive screening test for Hepatitis B or Syphilis.
  • History or evidence of Diabetes Mellitus.
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  • Presence of any symptoms or signs of either active TB or latent tuberculosis infection 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, and/or
  • Mantoux Tuberculin PPD skin test greater than or equal to 10 mm (read 48-72hrs post-test)
  • Presence of signs or symptoms of any reported acute infectious disease at the time of screening.
  • 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 which is not considered by the investigator to be clinically significant will not represent exclusion.
  • Vaccination with routine BCG before study vaccination.
  • 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 with a 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 with a digital thermometer on at least 2 occasions not less than 6 hours apart.
  • Clinically suspected neonatal 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.
  • Any clinically significant laboratory abnormalities on screening blood samples or urinalysis.

Trial locations and contacts

1 site in 1 country.

South Africa1 site

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

    Cape Town

Other trials in South Africa

About this study

Official title: Phase II Open Label, Randomized, Controlled Study to Evaluate Safety and Immunogenicity of VPM1002 in Comparison With BCG in HIV-unexposed, BCG Naive Newborn Infants in South Africa

Goal of VPM 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 (Kaufmann, 2007a; Grode et al., 2005). The vaccine is formulated as live lyophilised bacteria to be re-suspended before intradermal injection. The preceding clinical trials in 80 volunteers in Germany and 24 volunteers in Bloemfontein, South Africa indicated immunogenicity and safety being sufficient for proceeding with the clinical development in newborn infants. Hence, the current study is commenced at Stellenbosch University, South Africa. This is the first investigation of VPM1002 in newborn infants.

Conditions
Tuberculosis
Being tested
VPM1002, BCG
Keywords
Tuberculosis, Vaccine, Live vaccine, rBCG
Medical subject headings
Tuberculosis

What participants receive

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

  • VPM1002Biological

    Tuberculosis vaccine

  • BCGBiological

    commercially available live vaccine BCG

Study groups in NCT01479972
Study groupRoleWhat they receive
VPM1002ExperimentalNot described
Receives: Biological: VPM1002
BCGActive comparatorNot described
Receives: Biological: BCG

What is being measured

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

  1. Safety

    Safety and tolerability as assessed by monitoring of adverse events (incidence, time profile, other profiles, and including local or regional reactions at the vaccination site), physical examination, vital signs, standard laboratory safety parameters, including haematology, clinical chemistry and urinalysis.

    Measured: Six months

Secondary outcomes (1)

  1. Immunogenicity

    IFN-gamma-WB-ELISA: concentration of IFN-gamma per ml supernatant after stimulation. ICS (FACS): number of CD4+ T-lymphocytes ("single-positive-cells", "double-positive-cells", "triple-positive-cells", "multi-positive-cells (positive for at least two of IFN-gamma, TNF-alpha or IL-2) after 16 hours stimulation; per total number of lymphocytes. ICS (FACS): number of CD8+ T-lymphocytes("single-positive-cells", "double-positive-cells", "triple-positive-cells", "multi-positive-cells (positive for at least two of IFN-gamma, TNF-alpha or IL-2) after 16 hours stimulation.

    Measured: baseline, day 14, week 6, 12, 18, month 6

Timeline

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

  1. First posted28 Nov 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionNov 2012
  4. Study completionNov 2012

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
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01479972
Sponsor's protocol ID
VPM1002-ZA-2.12TB
Other IDs
DOH-27-0911-3677
Status last verified
Oct 2013
First submitted
18 Nov 2011
Last updated
29 Oct 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Loxton AG, Knaul JK, Grode L, Gutschmidt A, Meller C, Eisele B, Johnstone H, van der Spuy G, Maertzdorf J, Kaufmann SHE, Hesseling AC, Walzl G, Cotton MF. Safety and Immunogenicity of the Recombinant Mycobacterium bovis BCG Vaccine VPM1002 in HIV-Unexposed Newborn Infants in South Africa. Clin Vaccine Immunol. 2017 Feb 6;24(2):e00439-16. doi: 10.1128/CVI.00439-16. Print 2017 Feb.

    PubMed 27974398

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VPM1002 and BCG in people with Tuberculosis, run by Serum Life Science Europe GmbH at 1 site 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 19 inclusion and 23 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 29 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Safety (time frame: Six 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 NCT01479972, 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 29 Oct 2013.

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