Tuberculosis Clinical Trial
— MTBVAC-Ph1bOfficial title:
A Randomized, Double-blind, Dose-escalation Clinical Trial of the Safety, Reactogenicity and Immunogenicity of MTBVAC Compared to BCG Vaccine SSI, in Newborns Living in a Tuberculosis Endemic Region With a Safety Arm in Adults
Verified date | April 2018 |
Source | Biofabri, S.L |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Randomized, controlled, double blind clinical trial in 2 stages (adult stage, infant stage). The first stage includes 18 HIV uninfected, QFT negative, BCG vaccinated, adult participants, randomized 1:1 to receive BCG Vaccine SSI or MTBVAC at equivalent dose (5x10E05 CFU/0.1mL) (n=9 in each group). Upon favourable safety review by the DSMB for all 18 adults up to day 28 after study vaccination, the second stage will commence in thirty-six (36) HIV unexposed, BCG naïve, newborn infants, randomized 1:3 to receive BCG Vaccine SSI or MTBVAC at one of three different dose levels ( (n=9 in each group).
Status | Completed |
Enrollment | 54 |
Est. completion date | March 2018 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 50 Years |
Eligibility |
Inclusion Criteria: Adult stage: Inclusion criteria: 1. Male or female, age 18 to 50 years 2. Written informed consent, including permission for access to medical records and an HIV test. 3. Available for study follow up and display a willingness and capacity to comply to study procedures. 4. In good general health, as assessed by medical history and a focused physical examination. 5. HIV test (rapid test, ELISA, or PCR) negative 6. Quantiferon®-TB Gold (Cellestis) test for latent TB infection negative within 3 weeks of enrolment 7. BCG vaccination at birth as confirmed by history or the presence of a BCG scar 8. In the case of female participants, a negative urine or serum pregnancy test at enrolment, not lactating, and willingness to use an acceptable method of contraception to avoid pregnancy for the duration of the study Infant Stage: Inclusion Criteria: 1. Male or female neonates within 96 hours of birth. 2. Written informed parental consent, including permission to access medical records and results of antenatal HIV tests. 3. Infant participants and their caregivers available for study follow-up and display the willingness and capacity to comply with study procedures. 4. Neonates must be in good general health as assessed by antenatal history, delivery records, and focused physical examination. 5. Birth weight more than or equal to 2500 grams. 6. Apgar score at 5 minutes more than or equal to 7. 7. A maternal HIV test result (rapid test, ELISA or PCR) taken during pregnancy must be available, documented and negative. 8. Estimated gestational age more than or equal to 38 weeks Exclusion Criteria: Adult stage Exclusion criteria 1. A history or evidence of an acute or chronic medical or surgical condition likely to affect the safety, reactogenicity, or immunogenicity of the investigational vaccine 2. Skin condition, bruising or birth mark at the intended injection site. 3. History or evidence of previous or current active TB disease 4. History of a household contact with active TB disease who has received less than 2 months treatment Infant Stage Exclusion criteria: 1. Infant must not have received routine BCG vaccination prior to enrolment. 2. Antenatal, intrapartum, or postnatal medical or surgical condition that may affect the safety, reactogenicity, or immunogenicity of the investigational vaccine. 3. Maternal HIV test (rapid test, ELISA or PCR) not performed antenatally, HIV test results not available, or HIV test result known positive. 4. Maternal or other household contact with newly diagnosed or incompletely treated active TB disease. |
Country | Name | City | State |
---|---|---|---|
South Africa | South African Tuberculosis Vaccine Initiative, Brewelskloof Hospital | Worcester | Western Cape |
Lead Sponsor | Collaborator |
---|---|
Biofabri, S.L | South African Tuberculosis Vaccine Initiative, Triclinium Clinical Trial Project Management (Pty) Ltd., TuBerculosis Vaccine Initiative, Universidad de Zaragoza |
South Africa,
Aguilo N, Uranga S, Marinova D, Monzon M, Badiola J, Martin C. MTBVAC vaccine is safe, immunogenic and confers protective efficacy against Mycobacterium tuberculosis in newborn mice. Tuberculosis (Edinb). 2016 Jan;96:71-4. doi: 10.1016/j.tube.2015.10.010. Epub 2015 Nov 30. — View Citation
Arbues A, Aguilo JI, Gonzalo-Asensio J, Marinova D, Uranga S, Puentes E, Fernandez C, Parra A, Cardona PJ, Vilaplana C, Ausina V, Williams A, Clark S, Malaga W, Guilhot C, Gicquel B, Martin C. Construction, characterization and preclinical evaluation of MTBVAC, the first live-attenuated M. tuberculosis-based vaccine to enter clinical trials. Vaccine. 2013 Oct 1;31(42):4867-73. doi: 10.1016/j.vaccine.2013.07.051. Epub 2013 Aug 17. — View Citation
Spertini F, Audran R, Chakour R, Karoui O, Steiner-Monard V, Thierry AC, Mayor CE, Rettby N, Jaton K, Vallotton L, Lazor-Blanchet C, Doce J, Puentes E, Marinova D, Aguilo N, Martin C. Safety of human immunisation with a live-attenuated Mycobacterium tuberculosis vaccine: a randomised, double-blind, controlled phase I trial. Lancet Respir Med. 2015 Dec;3(12):953-62. doi: 10.1016/S2213-2600(15)00435-X. Epub 2015 Nov 17. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and reactogenicity in infants and adults: includes injection site and systemic and regional adverse events, solicited and unsolicited. A diary card will be for solicited local, regional, and systemic adverse event data. | Six (6) months post-study vaccination | ||
Secondary | Primary immunogenicity analysis (in infants only): Measure of frequencies and co-expression patterns of CD4 and CD8 T cells expressing specific cytokines in whole blood. | Six (6) months post-study vaccination |
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