Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02814708 |
| Other study ID # |
BioMed 0515 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
May 2016 |
| Est. completion date |
January 2021 |
Study information
| Verified date |
December 2021 |
| Source |
Biomedizinische Forschungs gmbH |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Toxic Shock Syndrome (TSS) is a severe condition with high morbidity and mortality from the
hosts overwhelming inflammatory response and cytokine storm. Staphylococcal superantigen
toxins are the main causative agents. Toxic shock syndrome toxin (TSST-1) being responsible
for almost all of menstruation associated and more than 50% of all other cases. There is no
specific therapy.
The aim of this study is to extend the safety and tolerability of two doses of the BioMed
recombinant toxic shock syndrome toxin (rTSST-1) Variant Vaccine after one to three
vaccinations in healthy adults. The second aim of the study is to measure immunogenicity and
persistence of antibodies which produced in response to treatment with the BioMed rTSST-1
Variant Vaccine over a period of 12 months. These antibodies are expected to be important in
prevention and mitigation of the diseases. 140 healthy adults, male and female, age 18-64
years will be assigned to 7 groups comprising two doses of the vaccine or adjuvant at the
Department of Clinical Pharmacology of the Medical University of Vienna. The patients will be
monitored for vital signs, hematology, clinical chemistry, and antibodies against TSST-1.
Immunization will be repeated 3 months after the first with the same dose and 6 months after
the second immunization in the respective groups.
Antibodies will be determined through monitoring TSST-1 binding antibodies as assessed
through ELISA and neutralizing antibodies (exploratory endpoint) as assessed by inhibition of
T cell activation (3H Thymidine incorporation; ≥ 50%).
Description:
The BioMed rTSST-1 Variant Vaccine has been developed by Biomedizinische ForschungsgmbH as
one component of a polyvalent staphylococcal vaccine for the prevention of toxic shock and
hyperimmunization of donors for the production of TSST-1 immunoglobulin.
This is a prospective, randomized, parallel control, phase 2 study of extended safety, local
tolerance, immunogenicity, and TSST-1 antibody persistence in healthy adults, who have been
vaccinated with one, two or three doses of the BioMed rTSST1 Variant Vaccine compared to
adjuvant.
Over a period of 60 days prior to entry into the study, 145 male and female subjects 18 - 64
years in age will be screened for eligibility. Screening criteria will include physical
examination, medical history, pregnancy/ adequate contraception in females, HIV Ab, hepatitis
C virus antibodies (HCV Ab), hepatitis B antigen (HBs Ag) and TSST-1 Ab. 140 qualified
subjects will be entered into the study.
Group 1 will receive 10 µg of rTSST-1 Variant Vaccine and two administrations of Adjuvant;
Group 2 will receive the same dose of Vaccine twice and one dose of Adjuvant; and Group 3
will be injected the 10 µg of the Vaccine three times. Groups 4 to 6 will be given 100 µg of
Vaccine following the same schedule. Group 7 will receive Al(OH3) adjuvant three times.
Prior to, and 24 h (+3 h) after each vaccination, the subjects will be examined for vital
signs. Blood will be drawn for hematology, clinical chemistry tests, and C-reactive protein.
Local reactions and adverse events will be assessed in all post vaccination visits.
The subjects will be followed up for a period of 3 months (± 2 weeks) or optionally 18 months
(± 12 weeks) if they decide to take part in the long-term follow-up, during which they will
return to the clinic every three months (± 2 weeks). Tests performed will include vital
signs, local reactions, clinical chemistry, C-reactive protein. Adverse events will be
recorded.
Binding and neutralizing TSST-1 antibodies will be determined prior to each vaccination and
every three months during the treatment and follow-up periods.
Each participant will be in the study for 12 to 14, or optionally 24 months, if they decide
to take part in the long-term follow-up.
Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a
4-fold increase in TSST-1 Ab titer. Neutralization will be defined as a three-fold increase
of neutralization titer.
