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Outcome Measures

Primary Outcomes (6)

PRNT80 ≥ 1:40 after primary series
% vaccinated subjects with PRNT80 ≥ 1:40 after primary series (initial responders).
Between Days 28-42
PRNT80 ≥ 1:40 after 6-month mandatory booster dose
% vaccinated subjects with PRNT80 ≥ 1:40 after 6-month mandatory booster dose (initial responders only).
7 months
(PRNT80 < 1:40) who responded with a PRNT80 ≥ 1:40
% initial non-responders (PRNT80 \< 1:40) who responded with a PRNT80 ≥ 1:40 after 1, 2, 3, or 4 booster doses.
up to 5 years
Median duration of PRNT80 ≥ 1:40 in initial responders
Median duration of PRNT80 ≥ 1:40 in initial responders after the primary series and 6-month mandatory booster dose.
up to 5 years
Median duration of PRNT80 ≥ 1:40 in initial non-responders
Median duration of PRNT80 ≥ 1:40 in initial non-responders after the first booster dose that results in PRNT80 ≥ 1:40.
up to 5 years

Secondary Outcomes (4)

Subjects without symptoms
5 years
Subjects with any category of local reaction (grade 1-4).
5 years
Subjects with mild, moderate, severe, and potentially life-threatening systemic reactions (grade 1-4).
5 years
Subjects with generalized allergic reactions
5 years

Interventions

Inactivated, Dried (TSI-GSD 200), RVF VaccineBiological

All subjects: 1.0-mL (SQ)doses on day 0, once between days 7 \& 14, \& once between days 28-42. Initial responders: A 6-month mandatory vaccine booster dose (1.0 mL, SQ) will be given if the PRNT80 is ≥1:40 after the primary series. Subsequent booster doses will be given for PRNT80 titer \<1:40. Initial non-responders: Individual who has a PRNT80 titer \<1:40 following the primary series may be administered a booster dose before 6 months. The individual will not receive the mandatory 6-month booster dose. Once an initial non-responder achieves PRNT80 ≥1:40, additional booster doses will be given for subsequent PRNT80 \<1:40). All subjects: RVF booster dose will be administered within 90 days after a PRNT80 result of \<1:40.

primary vaccination with boost

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Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

At least 18 years old.
Females of childbearing potential must have a negative serum or urine pregnancy test within 48 hours before each vaccination. Females will be advised not to become pregnant for 3 months after the primary series and each booster dose.

MeSH Terms

Conditions

Rift Valley FeverHemorrhagic Fevers, ViralVirus DiseasesNervous System DiseasesArbovirus Infections

Interventions

Desiccation

Condition Hierarchy (Ancestors)

Hepatitis, Viral, AnimalHepatitis, AnimalInfectionsMosquito-Borne DiseasesVector Borne DiseasesBunyaviridae InfectionsRNA Virus InfectionsHepatitis

Study Design

Study Type

interventional

Phase

phase 2

Allocation

Masking

NONE

Purpose

PREVENTION

Intervention Model

SINGLE GROUP

Model Details: Open-label, Phase 2, uncontrolled, vaccine study to assess the safety, immunogenicity of RVF (inactivated) vaccine (1.0 mL subcutaneous, SQ). Three primary series doses; for responders to the vaccine (PRNT80 ≥ 1:40), 6 month mandatory vaccine booster dose; Three primary series doses; for non-responders to the vaccine (PRNT80 \< 1:40) may be boosted before 6 months.

Sponsor Type

FED

Responsible Party

SPONSOR

Safety and Immunogenicity Study of Rift Valley Fever Vaccine, Inactivated

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (6)

Secondary Outcomes (4)

Study Arms (1)

primary vaccination with boost

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (6)

Secondary Outcomes (4)

Study Arms (1)

primary vaccination with boost

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations