Safety and Immunogenicity of Co-Administered Hookworm Vaccine Candidates Na-GST-1 and Na-APR-1 in Gabonese Adults

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02126462
• Date of registration: 28/04/2014
• Prospective Registration: Yes
• Primary sponsor: Baylor College of Medicine
• Public title: Safety and Immunogenicity of Co-Administered Hookworm Vaccine Candidates Na-GST-1 and Na-APR-1 in Gabonese Adults
• Scientific title: Randomized, Controlled, Phase 1 Study to Assess Safety and Immunogenicity of Co-administered Hookworm Vaccine Candidates Na-GST-1 and Na-APR-1 Adjuvanted With Alhydrogel® and Gluco-pyranosylphospho-lipid A in Gabonese Adults
• Date of first enrolment: November 2014
• Target sample size: 32
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02126462
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

Gabon

Contacts

• Name: Ayola Adegnika, MD
• Affiliation: Centre de Recherches Medicales de Lambarené

Key inclusion & exclusion criteria

Inclusion Criteria:

- Males or females between 18 and 50 years, inclusive, who are long-term residents of
Gabon.

- Good general health as determined by means of the screening procedure.

- Assumed availability for the duration of the trial (12 months).

- Willingness to participate in the study as evidenced by signing the informed consent
document.

- Negative for hookworm during screening, or if found to be infected with hookworm, has
completed a course of three doses of albendazole.

Exclusion Criteria:

- Pregnancy as determined by a positive urine hCG (if female).

- Participant unwilling to use reliable contraception up until one month following the
third immunization (if female and not surgically sterile, abstinent or at least 2
years post-menopausal).

- Currently lactating and breast-feeding (if female).

- Inability to correctly answer all questions on the informed consent comprehension
questionnaire.

- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic,
rheumatologic, autoimmune, diabetes, or renal disease by history, physical
examination, and/or laboratory studies.

- 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).

- Laboratory evidence of hematologic disease (absolute leukocyte count <3500/mm3;
absolute leukocyte count >11.0 x 103/mm3; hemoglobin <10.000 g/dl [females] or <12.0
g/dl [males]; or, platelet count <140,000/mm3).

- 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 or for the duration of the study.

- 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.

- Severe asthma as defined by the need for daily use of inhalers or emergency
room/clinic visit or hospitalization within 6 months of the volunteer's planned first
vaccination in the study.

- Positive for HCV

- Positive ELISA for HBsAg.

- Positive for HIV infection

- Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within
30 days of starting this study or expect to use for the duration of the study.

- Receipt of a live vaccine within past 4 weeks or a killed vaccine within past 2 weeks
prior to entry into the study.

- History of a surgical splenectomy.

- Receipt of blood products within the 6 months prior to entry into the study.

- Previous receipt of a primary series of any hepatitis B vaccine.



Age minimum: 18 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hookworm Disease

Hookworm Infection

Intervention(s)

Biological: Na-APR-1 (M74)/Alhydrogel®

Biological: Hepatitis B vaccine

Biological: Na-GST-1/Alhydrogel®

Primary Outcome(s)

Vaccine-related Adverse Events [Time Frame: Day 360]

Secondary Outcome(s)

Exploratory studies of memory B-cell responses [Time Frame: Days 14, 28, 42, 56, 180, 194, 208, 270, 360]

Duration of antibody response to Na-GST-1 and Na-APR-1 (M74) [Time Frame: Day 14, 28, 42, 56, 180, 194, 208, 270, 360]

IgG response to Na-GST-1 and Na-APR-1 (M74) [Time Frame: Day 194]

Secondary ID(s)

HV-001

602843-2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors