Study of Na-APR-1 (M74)/Alhydrogel® Co-administered With Na-GST-1/Alhydrogel in Brazilian Adults
Phase 1 Study of the Safety and Immunogenicity of Na-APR-1 (M74)/Alhydrogel® Co-administered With Na-GST-1/Alhydrogel® in Brazilian Adults
1 other identifier
interventional
60
1 country
1
Brief Summary
Na-GST-1 and Na-APR-1 are proteins expressed during the adult stage of the Necator americanus hookworm life cycle that are thought to play a role in the parasite's degradation of host hemoglobin for use as an energy source. Vaccination wtih recombinant GST-1 or APR-1 has protected dogs and hamsters from infection in challenge studies. This study will evaluate the safety and immunogenicity of co-administering Na-GST-1 and Na-APR-1 to healthy Brazilian adults living in an area of endemic hookworm infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2015
CompletedFirst Posted
Study publicly available on registry
June 19, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedDecember 3, 2019
November 1, 2019
1.4 years
June 17, 2015
November 29, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Frequency of solicited injection site and systemic reactogenicity, graded by severity, on the day of each study vaccination through 14 days after each study vaccination.
14 days post-vaccination
Frequency of study vaccine-related serious adverse events from the time of the first study vaccination through approximately 9 months after the last study vaccination.
Day 380
Frequency of clinical safety laboratory adverse events.
Day 380
Frequency of unsolicited adverse events, graded by severity, from the time of each study vaccination through approximately 1 month after each study vaccination.
30 days post-vaccination
Frequency of new-onset chronic medical conditions through approximately 9 months after the third study vaccination.
Day 380
Frequency of Adverse Events of Special Interest through approximately 9 months after the third study vaccination.
Day 380
Secondary Outcomes (1)
The IgG level by an indirect enzyme-linked immunosorbent assay (ELISA) on approximately Day 126.
Day 126
Other Outcomes (1)
The IgG antibody response, by an indirect enzyme-linked immunosorbent assay (ELISA) at approximately 7, 14, and 28 days after each vaccination, and approximately 3, 6, and 9 months after the third dose.
7, 14, and 28 days after each vaccination, and approximately 3, 6, and 9 months after the third dose
Study Arms (6)
Group 1
EXPERIMENTAL* 5 subjects will receive 10µg Na-APR-1 (M74)/Alhydrogel with Sterile Saline Placebo administered to the alternate arm. * 5 subjects will receive 10µg Na-APR-1 (M74)/Alhydrogel with 100µg Na-GST-1/Alhydrogel plus GLA-AF administered to the alternate arm.
Group 2
EXPERIMENTAL* 5 subjects will receive 10µg Na-APR-1 (M74)/Alhydrogel plus GLA-AF, with Sterile Saline Placebo administered to the alternate arm. * 5 subjects will receive 10µg Na-APR-1 (M74)/Alhydrogel plus GLA-AF, with 100µg Na-GST-1/Alhydrogel plus GLA-AF administered to the alternate arm.
Group 3
EXPERIMENTAL* 5 subjects will receive 30µg Na-APR-1 (M74)/Alhydrogel, with Sterile Saline Placebo administered to the alternate arm. * 5 subjects will receive 30µg Na-APR-1 (M74)/Alhydrogel, with 100µg Na-GST-1/Alhydrogel plus GLA-AF administered to the alternate arm.
Group 4
EXPERIMENTAL* 5 subjects will receive 30µg Na-APR-1 (M74)/Alhydrogel plus GLA-AF, with Sterile Saline Placebo administered to the alternate arm. * 5 subjects will receive 30µg Na-APR-1 (M74)/Alhydrogel plus GLA-AF, with 100µg Na-GST-1/Alhydrogel plus GLA-AF administered to the alternate arm.
Group 5
EXPERIMENTAL* 5 subjects will receive 100µg Na-APR-1 (M74)/Alhydrogel, with Sterile Saline Placebo administered to the alternate arm. * 5 subjects will receive 100µg Na-APR-1 (M74)/Alhydrogel, with 100µg Na-GST-1/Alhydrogel plus GLA-AF administered to the alternate arm.
Group 6
EXPERIMENTAL* 5 subjects will receive 100µg Na-APR-1 (M74)/Alhydrogel plus GLA-AF, with Sterile Saline Placebo administered to the alternate arm. * 5 subjects will receive 100µg Na-APR-1 (M74)/Alhydrogel plus GLA-AF, with 100µg Na-GST-1/Alhydrogel plus GLA-AF administered to the alternate arm.
Interventions
Eligibility Criteria
You may qualify if:
- Males or non-pregnant females between 18 and 45 years, inclusive.
- Good general health as determined by means of the screening procedure.
- Available for the duration of individual subject study participation (16 months).
- Willingness to participate in the study as evidenced by signing the informed consent document.
You may not qualify if:
- Pregnancy as determined by a positive urine hCG (if female).
- Subject unwilling to use reliable contraception (as described in Section 2.3.1) from 30 days prior to the first immunization and up until one month following the third immunization (if female and not surgically sterile, abstinent or at least 2 years post-menopausal, or determined otherwise by medical evaluation to be sterile).
- Currently lactating and breast-feeding (if female).
- Inability to correctly answer all questions on the informed consent comprehension questionnaire.
- Has a diagnosis of schizophrenia, bipolar disease or other major psychiatric condition that would make compliance with study visits/procedures difficult (e.g., subject with psychoses or history of suicide attempt or gesture in the 3 years before study entry, ongoing risk for suicide).
- Known or suspected immunodeficiency.
- Laboratory evidence of liver disease (alanine aminotransferase \[ALT\] greater than 1.25-times the upper reference limit).
- Laboratory evidence of renal disease (serum creatinine greater than 1.25-times the upper reference limit, or more than trace protein or blood on urine dipstick testing with the exception of greater than trace blood detected in females during menses).
- Laboratory evidence of hematologic disease (absolute leukocyte count \<3200/mm3; absolute leukocyte count \>10.8 x 103/mm3; hemoglobin \<11.4 g/dl \[females\] or \<12.1 g/dl \[males\]; or, platelet count \<130,000/mm3).
- Serum glucose (random) greater than 1.2-times the upper reference limit.
- Other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol.
- Participation in another investigational vaccine or drug trial within 30 days of starting this study.
- Previous receipt of the Na-GST-1/Alhydrogel® hookworm vaccine.
- Volunteer has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months.
- History of a severe allergic reaction or anaphylaxis.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Baylor College of Medicinelead
- Centro de Pesquisas René Rachoucollaborator
- Johns Hopkins Universitycollaborator
- University of California, San Franciscocollaborator
- George Washington Universitycollaborator
Study Sites (1)
Americaninhas Vaccine Center
Americaninha, Minas Gerais, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Diemert, MD
George Washington University
- STUDY DIRECTOR
Rodrigo Correa-Oliveira, PhD
Centro de Pesquisas René Rachou
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Sponsor
Study Record Dates
First Submitted
June 17, 2015
First Posted
June 19, 2015
Study Start
January 1, 2016
Primary Completion
June 1, 2017
Study Completion
December 1, 2017
Last Updated
December 3, 2019
Record last verified: 2019-11