Testing Pfs25-EPA/Alhydrogel as a Potential Malaria Transmission Blocking Vaccine

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01867463
• Date of registration: 16/05/2013
• Prospective Registration: No
• Primary sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Public title: Testing Pfs25-EPA/Alhydrogel as a Potential Malaria Transmission Blocking Vaccine
• Scientific title: Double Blind Dose-Escalating Randomized Controlled Phase 1 Study in Malaria Exposed Adults of the Safety and Immunogenicity of Pfs25-EPA/ Alhydrogel, a Transmission Blocking Vaccine Against Plasmodium Falciparum in Bancoumana, Mali
• Date of first enrolment: March 27, 2013
• Target sample size: 230
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01867463
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

Mali

Contacts

• Name: Sara A Healy, M.D.
• Affiliation: National Institute of Allergy and Infectious Diseases (NIAID)

Key inclusion & exclusion criteria

- INCLUSION CRITERIA:

All of the following criteria must be fulfilled for a subject to participate in this trial:

1. Adult age 18 45 years.

2. Known residents of the village of Bancoumana or immediate surrounding areas.

3. Available for the duration of the trial (approximately 2.5 years).

4. Good general health as a result of review of medical history and/or clinical testing
at the time of screening.

5. Willingness to participate in the study as evidenced by signing the informed consent
document, or by fingerprinting the consent document with the signature of a witness.

6. Willingness to undergo a HIV test.

7. Willingness to undergo direct skin feeds.

EXCLUSION CRITERIA:

A subject will be excluded from participating in this trial if any one of the following
criteria is fulfilled:

1. Pregnancy, as determined by a positive urine or serum human choriogonadotropin (beta
human chorionic gonadotropin ) test at any point during the study (if female).

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

3. Unable or unwilling to use reliable contraception for a minimum of one month prior to
the first vaccination to three months after the last vaccination (if female). Reliable
birth control includes: pharmacologic contraceptives including oral, parenteral, and
transcutaneous delivery; condoms with spermicide; diaphragm with spermicide; surgical
sterilization; vaginal ring; transdermal patch; intrauterine device; abstinence; and
postmenopause.

(Note: If screening of the female subject occurs < 1 month prior to first vaccination,
a negative serum pregnancy test at time of screening and at enrollment (first
vaccination) and agreement to use of reliable contraception for the duration of the
study until three months after the fourth vaccination is acceptable.)

4. Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator
affects the ability of the participant to understand and cooperate with the study
protocol.

5. Hemoglobin, WBC, and platelets outside the local laboratory-defined upper limit of
normal (subjects may be included at the investigator s discretion for not clinically
significant values outside of normal range).

6. Neutropenia (absolute neutrophil count <1250/mm3).

7. Alanine transaminase (ALT) or creatinine (Cr) level above the local laboratory-defined
upper limit of normal.

8. Positive test for hepatitis C virus (HCV).

9. Positive test for hepatitis B (HBsAg).

10. Positive test for human immunodeficiency virus (HIV).

11. Known immunodeficiency syndrome.

12. Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine,
rheumatologic, autoimmune, hematological, or renal disease by history, physical
examination, and/or laboratory studies including urinalysis.

13. Subject has had medical, occupational, or family problems as a result of alcohol or
illicit drug use during the past 12 months.

14. History of a severe allergic reaction or anaphylaxis.

15. History of a severe reaction to mosquito bites.

16. Severe asthma, defined as asthma that is unstable or required emergent care, urgent
care, hospitalization or intubation during the past 2 years, or that has required the
use of oral or parenteral corticosteroids at any time during the past 2 years.

17. Clinically significant reactive airway disease that does not respond to
bronchodilators.

18. History of a surgical splenectomy.

19. Use of chronic (greater than or equal to 14 days) oral or intravenous corticosteroids
(excluding topical or nasal) at immunosuppressive doses (i.e., prednisone >10 mg/ day)
or immunosuppressive drugs within 30 days of starting this study.

20. Receipt of a live vaccine within past four weeks or a killed vaccine within past two
weeks prior to entry into the study.

21. Receipt of blood products within the past 6 months.

22. Previous participation in a malaria vaccine trial.

23. History of receiving any investigational product within the past 30 days.

24. Refusal to allow storage of samples for future research at the time of enrollment.

25. Any medical, psychiatric, social, or occupational condition that, in the judgment of
the Principal Investigator (PI), would interfere with the evaluation of study
objectives or increase risk to the subject.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: All

Health Condition(s) or Problem(s) studied

Malaria

Intervention(s)

Biological: Menactra

Biological: Euvax B

Biological: Pfs25-EPA/Alhydrogel

Primary Outcome(s)

Incidence of local and systemic adverse events and serious adverse events. [Time Frame: 12 months following the last vaccination; and for 6 months following the fourth vaccination.]

Secondary Outcome(s)

Antibody responses as measured by ELISA against recombinant Pfs25 and EPA, and B cell responses. Functional activity of the induced antibody will be assessed by direct transmission blocking assays [Time Frame: 12 months following the last vaccination; and for 6 months following the fourth vaccination.]

Secondary ID(s)

999913109

13-I-N109

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Malaria Research and Training Center, Bamako, Mali