Safety and Immunogenicity of Pfs25M-EPA/AS01 and Pfs230D1M-EPA/AS01 Vaccines, Transmission Blocking Vaccines Against Plasmodium Falciparum, at Full and Fractional Dosing in Adults in Mali

• Register: ClinicalTrials.gov
• Last refreshed on: 7 February 2022
• Main ID: NCT02942277
• Date of registration: 21/10/2016
• Prospective Registration: Yes
• Primary sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Public title: Safety and Immunogenicity of Pfs25M-EPA/AS01 and Pfs230D1M-EPA/AS01 Vaccines, Transmission Blocking Vaccines Against Plasmodium Falciparum, at Full and Fractional Dosing in Adults in Mali
• Scientific title: Phase 1 Dose Escalating, Double-Blind, Randomized Comparator Controlled Trial of the Safety andImmunogenicity of Pfs25M-EPA/AS01 and Pfs230D1M-EPA/AS01 Vaccines, Transmission Blocking Vaccines Against Plasmodium Falciparum at Full and Fractional Dosing in Adults in Mali
• Date of first enrolment: October 21, 2016
• Target sample size: 301
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02942277
• 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: Patrick E Duffy, M.D.
• Affiliation: National Institute of Allergy and Infectious Diseases (NIAID)

Key inclusion & exclusion criteria

-INCLUSION CRITERIA:

1. Age greater than or equal to 18 and less than or equal to 50 years.

2. Available for the duration of the trial.

3. Able to provide proof of identity to the satisfaction of the study clinician
completing the enrollment process.

4. In good general health and without clinically significant medical history in the
opinion of the investigator.

5. Females of childbearing potential must be willing to use reliable contraception (as
defined below) from 21 days prior to Study Day 0 (Study Day 476 for re-enrollment) and
then until 3 months after last vaccination.

- Reliable methods of birth control include one of the following: confirmed
pharmacologic contraceptives (parenteral) delivery; intrauterine or implantable
device.

- Reliable methods of birth control include concurrent use of a pharmacologic and a
barrier method, i.e. two of the following: confirmed pharmacologic contraceptives
(oral, transdermal) delivery or vaginal ring AND condoms with spermicide or
diaphragm with spermicide.

- Non-childbearing women will also be required to report date of last menstrual
period, history of surgical sterility (i.e. tubal ligation, hysterectomy) or
premature ovarian insufficiency (POI), and will have a baseline urine or serum
pregnancy test performed.

6. Willingness to have blood samples stored for future research.

7. Willingness to undergo DSFs (Arms 3c, 3d, 4c only).

8. Known resident of Bancoumana or Doneguebougou or surrounding area or known student or
long term resident (more than 1 year) of Bamako/Sotuba, Mali

EXCLUSION CRITERIA:

1. Pregnancy as determined by a positive urine or serum human choriogonadotropin
(beta-hCG) test (if female).

NOTE: Pregnancy is also a criteria for discontinuation of any further dosing or
non-safety related interventions for that subject.

2. Currently breast-feeding (if female).

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

4. Hemoglobin, WBC, absolute neutrophils, and platelets outside the local
laboratory-defined limits of normal (subjects may be included at the investigator s
discretion for not clinically significant values outside of normal range and less than
or equal to Grade 1).

5. Alanine transaminase (ALT) or creatinine (Cr) level above 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 and less than or equal to
Grade 1).

6. Infected with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or
hepatitis B (HBV).

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

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

9. Participation or planned participation in a clinical trial with an investigational
product prior to completion of the follow up visit 28 days following last vaccination
OR planned participation in an investigational vaccine study until the last required
protocol visit

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

11. History of a severe allergic reaction or anaphylaxis.

12. 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.

13. Pre-existing autoimmune or antibody-mediated diseases including but not limited to:
systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis,
Sj(SqrRoot)(Delta)gren s syndrome, or autoimmune thrombocytopenia.

14. Known immunodeficiency syndrome.

15. Known asplenia or functional asplenia.

16. 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 Study Day 0.

17. Prior to Study Day 0 and every subsequent vaccination day, receipt of a live vaccine
within the past 4 weeks or a killed vaccine within the past 2 weeks.

18. Receipt of immunoglobulins and/or blood products within the past 6 months.

19. Previous receipt of an investigational malaria vaccine in the last 5 years.

20. History of severe reaction to mosquito bites (Arms 3c, 3d, 4c only)

21. History of allergy to the comparator vaccine (such as latex, yeast, or previous
Hepatitis B vaccine)

22. Known allergies or contraindications (such as significant cardiac disease; prolonged
QTc >450 ms; currently taking medications that may prolong your QTc; serious side
effects from Coartem in the past) to study treatment (Coartem
[artemether/lumefantrine]) (Arms 3c, 3d, 4c only)

23. Other condition that in the opinion of the investigator would jeopardize the safety or
rights of a participant participating in the trial, interfere with the evaluation of
the study objectives, or would render the subject unable to comply with the protocol.



Age minimum: 18 Years
Age maximum: 52 Years
Gender: All

Health Condition(s) or Problem(s) studied

Malaria

Intervention(s)

Other: AS01

Biological: Pfs25M-EPA

Biological: Menactra

Biological: Pfs230D1M-EPA

Other: Normal Saline

Biological: Engerix-B

Drug: Coartem

Primary Outcome(s)

Number of Participants With Local and Systemic Adverse Events in Year 2 [Time Frame: Within 7 days after each vaccination]

Number of Participants With Local and Systemic Adverse Events in Year 1 [Time Frame: Within 7 days after each vaccination]

Secondary ID(s)

17-I-N006

999917006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 28/01/2022
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02942277