NCT02337855

Brief Summary

This is a Phase I, first-in-human study of a vaccine against S. mansoni infection.The study will recruit 72 healthy adult males and non-pregnant females from a single clinical center to test two formulations of Sm-TSP-2 vaccine (using the Alhydrogel® only, and using Alhydrogel® plus GLA-AF), each at 3 different doses: 10ug, 30ug, and 100ug. The primary objective is to assess the safety and reactogenicity of ascending doses of Sm-TSP-2/Alhydrogel® (10ug, 30ug, or 100ug) with or without GLA-AF vaccine given as three doses administered on Days 1, 57, and 113.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 14, 2015

Completed
21 days until next milestone

Study Start

First participant enrolled

February 4, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2017

Completed
Last Updated

June 26, 2017

Status Verified

December 7, 2016

Enrollment Period

2 years

First QC Date

January 8, 2015

Last Update Submit

June 22, 2017

Conditions

Schistosomiasis

Keywords

IntestinalPichia pastorisS. mansoniSchistosomiasisSm-TSP-2/AlhydrogelSm-TSP-2/Alhydrogel/GLA-AFvaccine

Outcome Measures

Primary Outcomes (9)

  • The occurrence of new-onset chronic medical conditions (including AESI) through 12 months after the third study vaccination.

    Through 12 months after the third study vaccination ( Day 478)

  • The occurrence of solicited injection site reactogenicity on the day of each study vaccination through 7 days after each study vaccination

    Day 113-120

  • The occurrence of solicited injection site reactogenicity on the day of each study vaccination through 7 days after each study vaccination

    Day 57-64

  • The occurrence of solicited injection site reactogenicity on the day of each study vaccination through 7 days after each study vaccination.

    Day 1-8

  • The occurrence of solicited systemic reactogenicity on the day of each study vaccination through 7 days after each study vaccination.

    Day 113-120

  • The occurrence of solicited systemic reactogenicity on the day of each study vaccination through 7 days after each study vaccination

    Day 1-8

  • The occurrence of solicited systemic reactogenicity on the day of each study vaccination through 7 days after each study vaccination.

    Day 57-64

  • The occurrence of study vaccine-related SAEs from the time of the first study vaccination through approximately 12 months after the last study vaccination

    Day 1-12 months after the last study vaccination

  • The occurrence of vaccine-related clinical safety laboratory adverse events

    Day 1-478

Secondary Outcomes (2)

  • The IgG antibody response using an indirect enzyme-linked immunosorbent assay (ELISA) on the day of each dose, 14 days after each dose, and 3 and 6 months after the third dose of Sm-TSP-2/Alhydrogel (10ug, 30ug, or 100ug) with or without GLA-AF

    Days 1, 5, 57, 71, 113,127, 203 and 293

  • The IgG level using an indirect enzyme-linked immunosorbent assay (ELISA) at Day 127

    Day 127

Study Arms (9)

Group A

EXPERIMENTAL

N=10 subjects will receive single dose intramuscular (IM) 10mcg Sm-TSP-2/Alhydrogel® on Day1, 57 and 113

Biological: Sm-TSP-2/Alhydrogel

Group B

EXPERIMENTAL

N=10 subjects will receive single dose intramuscular (IM) 10mcg Sm-TSP-2/Alhydrogel®/GLA-AF on Day 1, 57 and 113

Biological: Sm-TSP-2/Alhydrogel/GLA-AF

Group C

PLACEBO COMPARATOR

N= 4 subjects will receive single dose intramuscular (IM) Placebo (normal saline (0.9% NaCl) on Day 1, 57 and 113

Other: Placebo

Group D

EXPERIMENTAL

N=10 subjects will receive single dose intramuscular (IM) 30mcg Sm-TSP-2/Alhydrogel® on Day 1, 57 and 113

Biological: Sm-TSP-2/Alhydrogel

Group E

EXPERIMENTAL

N=10 subjects will receive single dose intramuscular (IM) 30mcg Sm-TSP-2/Alhydrogel®/GLA-AF on Day 1, 57 and 113

Biological: Sm-TSP-2/Alhydrogel/GLA-AF

Group F

PLACEBO COMPARATOR

N= 4 subjects will receive single dose intramuscular (IM) Placebo (normal saline (0.9% NaCl) on Day 1, 57 and 113

Other: Placebo

Group G

EXPERIMENTAL

N=10 subjects will receive single dose intramuscular (IM) 100mcg Sm-TSP-2/Alhydrogel® on Day 1, 57 and 113

Biological: Sm-TSP-2/Alhydrogel

Group H

EXPERIMENTAL

N=10 subjects will receive single dose intramuscular (IM) 100mcg Sm-TSP-2/Alhydrogel®/GLA-AF on Day 1, 57 and 113

Biological: Sm-TSP-2/Alhydrogel/GLA-AF

Group I

PLACEBO COMPARATOR

N= 4 subjects will receive single dose intramuscular (IM) Placebo (normal saline (0.9% NaCl) on Day 1, 57 and 113

Other: Placebo

Interventions

PlaceboOTHER

Placebo: normal saline for parenteral administration. Group C. Group F, and Group I: single dose intramuscular (IM) Placebo (normal saline (0.9% NaCl) on Day 1, 57 and 113.

Group CGroup FGroup I
Sm-TSP-2/AlhydrogelBIOLOGICAL

Sm-TSP-2/Alhydrogel. Group A: single dose IM 10mcg Sm-TSP-2/Alhydrogel® on Day1, 57 and 113. Group D: single dose intramuscular (IM) 30mcg Sm-TSP-2/Alhydrogel® on Day 1, 57 and 113. Group G: single dose intramuscular (IM) 100mcg Sm-TSP-2/Alhydrogel® on Day 1, 57 and 113.

Group AGroup DGroup G
Sm-TSP-2/Alhydrogel/GLA-AFBIOLOGICAL

Sm-TSP-2/Alhydrogel/GLA-AF. Group B: single dose intramuscular (IM) 10mcg Sm-TSP-2/Alhydrogel®/GLA-AF on Day 1, 57 and 113. Group E: single dose intramuscular (IM) 30mcg Sm-TSP-2/Alhydrogel®/GLA-AF on Day 1, 57 and 113. Group H: single dose intramuscular (IM) 100mcg Sm-TSP-2/Alhydrogel®/GLA-AF on Day 1, 57 and 113.

Group BGroup EGroup H

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor College of Medicine - Molecular Virology and Microbiology

Houston, Texas, 77030-3411, United States

Location

MeSH Terms

Conditions

Schistosomiasis

Condition Hierarchy (Ancestors)

Trematode InfectionsHelminthiasisParasitic DiseasesInfectionsVector Borne Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2015

First Posted

January 14, 2015

Study Start

February 4, 2015

Primary Completion

January 27, 2017

Study Completion

January 27, 2017

Last Updated

June 26, 2017

Record last verified: 2016-12-07

Locations

US(1)