Safety and Immunogenicity Study of Rift Valley Fever Vaccine
Raktažodžiai
Santrauka
apibūdinimas
Study Objectives:
The objectives of this two-part, primary immunization and booster dose, study are to continue to collect safety data on Rift Valley Fever (RVF) Vaccine, Inactivated (TSI-GSD 200); and, to continue to collect immunogenicity data on Rift Valley Fever (RVF) Vaccine, Inactivated (TSI-GSD 200) and analyze interim data to determine whether a 6-month dose is indicated; and, to provide potential protection for personnel at risk for occupational exposure to the RVF virus and collect data on incidence of occupational RVF infection (subclinical and clinical) in immunized personnel.
Datos
| Paskutinį kartą patikrinta: | 11/30/2019 |
| Pirmasis pateikimas: | 12/19/2007 |
| Numatytas registravimas pateiktas: | 12/30/2007 |
| Pirmas paskelbtas: | 01/01/2008 |
| Paskutinis atnaujinimas pateiktas: | 12/29/2019 |
| Paskutinis atnaujinimas paskelbtas: | 01/02/2020 |
| Pirmųjų rezultatų pateikimo data: | 02/21/2017 |
| Pirmojo QC rezultatų pateikimo data: | 06/15/2017 |
| Pirmųjų paskelbtų rezultatų data: | 07/13/2017 |
| : | 02/01/2017 |
| : | 02/01/2017 |
| : | 02/02/2017 |
| Faktinė studijų pradžios data: | 05/31/2004 |
| Numatoma pirminio užbaigimo data: | 04/30/2010 |
| Numatoma studijų užbaigimo data: | 04/30/2010 |
Būklė ar liga
Intervencija / gydymas
Biological: TSI-GSD 200 RVF Vaccine
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| Experimental: TSI-GSD 200 RVF Vaccine Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to < 1:40. | Biological: TSI-GSD 200 RVF Vaccine Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to < 1:40. |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 17 Years Į 17 Years |
| Tinkamos studijoms lytys | All |
| Priima sveikus savanorius | Taip |
| Kriterijai | Inclusion Criteria: Parts A & B: - At least 18 years old, or if active military duty, 17 years old, - Females of childbearing potential must agree to have a urine pregnancy test within 48 hours before receipt of each dose of vaccine. The test results must be negative. Females will be advised not to become pregnant for 3 months after the primary series and each booster dose, and must not be breast-feeding, - Subject must be actively enrolled in the SIP to be vaccinated at USAMRIID or be otherwise authorized (with documentation) by the DOD - Subjects must be at risk for exposure to RVF virus, - Subjects must have an up-to-date (within 1 year) medical history, physical examination, and laboratory tests in their charts and be medically cleared for participation by an investigator. Examinations or tests may be repeated within 1 year at the discretion of the enrolling physician. - Volunteer must have signed and dated the approved informed consent (Volunteer Agreement Explanation and Affidavit). Additional Inclusion Criteria for Part B: • Completion of primary series and any follow-up titer (PRNT80) < 1:40 from the current or a previous RVF IND 365 protocol. Exclusion Criteria Parts A & B: - Clinically significant abnormal lab results including evidence of Hepatitis C, Hepatitis B or carrier state, or elevated liver function tests. - Personal history of immunodeficiency or current treatment with immunosuppressive medication, at the discretion of the physician. - Confirmed HIV infection. - Any medical condition that, at the discretion of the physician, may jeopardize the safety of the volunteer. - Any serious or life-threatening allergies to any component of the vaccine: formalin, human serum albumin, neomycin, streptomycin - Administration of any other vaccine within 28 days of any dose of RVF vaccine. - Any unresolved adverse event resulting from a previous immunization. Additional Exclusion Criteria for Part B: • An adequate PRNT80 (≥ 1:40) after completion of primary series. |
Rezultatas
Pirminės rezultatų priemonės
1. Safety: All Incidences of Erythema [12 months]
Antrinės rezultatų priemonės
1. Immunogenicity: Geometric Mean Titers After 3rd Vaccination [28 days after dose 3]
2. Immunogenicity: Geometric Mean Titers Before 6-month Booster [Before 6-month booster]
3. Immunogenicity: Geometric Mean Titers at 12 Months [at 12 months]
4. Immunogenicity: Geometric Mean Titers After 6-month Booster [month 6 after dose 4]
