Initial Study of Malaria Vaccine Pfs25-EPA/Alhydrogel(Registered Trademark)

NCT01434381 | Completed Phase 1 DMC

• 2 other identifiers: 11-I-N237CIR 276
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- The malaria vaccine Pfs25-EPA/Alhydrogel may help block malaria parasites from developing in mosquitoes. When a mosquito bites a vaccinated person, the vaccine should prevent parasites from developing in the mosquito. As a result, the mosquito will not spread malaria to the next person it bites. However, the vaccine will not directly prevent people from getting sick with malaria. Researchers want to test the safety of and response to this vaccine. Objectives: \- To test the safety of the malaria vaccine Pfs25-EPA/Alhydrogel. Eligibility: \- Healthy volunteers between 18 and 50 years of age. Design:

• Participants will be screened with a medical history, physical exam, and blood tests.
• They will be assigned to a study group to have either two or three doses of the vaccine. Participants will have checkups after each dose of vaccine,
• The additional doses will be given 2 months or 2 and 4 months after the first vaccine.
• Participants will have regular blood tests to check the level of the response to the vaccine.
• They will be followed for up to 1 year after the last vaccine to have any additional tests as needed.

Conditions

Malaria

Keywords

Recombinant; Proteins; Antigen; Membrane; Assay; Malaria

Outcome Measures

Primary Outcomes (1)

• Incidence of local and systemic adverse events

  Subjects will be monitored for 30 minutes following each immunization. Subjects will return to the clinic on Days 3,7,14 and 28 following each vaccination for clinical assessments, and periodically thereafter until completion

  All adverse events will be recorded though Day 28 after each vaccination. The frequency of systemic and local AEs will be summarized.

Secondary Outcomes (1)

• To determine the antibody response to the Pfs25 protein vaccines as measured by ELISA and transmission blocking assays, and the effect on antibody responses of a third dose at four months

  ELISA testing will occur on vaccination days, 2 weeks after each vaccination, and periodically until study completion

Study Arms (1)

Pfs25-EPA/Alhydrogel

EXPERIMENTAL

Dose-escalation of Pfs25-EPA/Alhydrogel. Participants will receive 1 of 3 doses of Pfs25-EPA/Alhydrogel- 8 micro g, 16 micro g, or 47 micro g.

Biological: Pfs25-EPA/Alhydrogel

Interventions

Pfs25-EPA/Alhydrogel BIOLOGICAL

Pfs25-EPA/Alhydrogel

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All of the following criteria must be fulfilled for a volunteer to participate in this trial:
• Age between 18 and 50 years.
• Good general health as a result of review of medical history and/or clinical testing at the time of screening.
• Available for the duration of the trial.
• Willingness to participate in the study as evidenced by signing the informed consent document.
• If female: subject is willing to use reliable contraception methods for the period of at least 1month (2 months for oral contraceptive pills) prior to first vaccination to 3 months after last vaccination. Reliable methods of birth control include: pharmacologic contraceptives including oral, parenteral, and transcutaneous delivery; condoms with spermicide; diaphragm with spermicide; surgical sterilization; vaginal ring; transdermal patch; intrauterine device; abstinence; and post-menopause.

You may not qualify if:

• A volunteer will be excluded from participating in this trial if any one of the following criteria is fulfilled:
• Pregnancy as determined by a positive urine or serum human choriogonadotropin (Beta-hCG) test at any point during the study (if female).
• Currently is lactating and breast-feeding (if female).
• 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.
• Neutropenia as defined by an absolute neutrophil count \< 1500/mm(3).
• Alanine transaminase (ALT) level above the laboratory-defined upper limit of normal.
• 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.
• Other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant participating in the trial or would render the subject unable to comply with the protocol.
• History of receiving any investigational product within the past 30 days.
• Receipt of antimalarial prophylaxis during the past 12 months, or planned travel to a destination which would require malaria prophylaxis during the period of participation.
• Prior malaria infection by history.
• Participant 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. This will be defined as:
• Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past 2 years, or that requires the use of oral or parenteral corticosteroids.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Related Publications (3)

• Birkett AJ. PATH Malaria Vaccine Initiative (MVI): perspectives on the status of malaria vaccine development. Hum Vaccin. 2010 Jan;6(1):139-45. doi: 10.4161/hv.6.1.10462. Epub 2010 Jan 29. No abstract available.

  PMID: 20009524 BACKGROUND

• Cheru L, Wu Y, Diouf A, Moretz SE, Muratova OV, Song G, Fay MP, Miller LH, Long CA, Miura K. The IC(50) of anti-Pfs25 antibody in membrane-feeding assay varies among species. Vaccine. 2010 Jun 17;28(27):4423-9. doi: 10.1016/j.vaccine.2010.04.036. Epub 2010 Apr 29.

  PMID: 20434549 BACKGROUND

• Coler RN, Baldwin SL, Shaverdian N, Bertholet S, Reed SJ, Raman VS, Lu X, DeVos J, Hancock K, Katz JM, Vedvick TS, Duthie MS, Clegg CH, Van Hoeven N, Reed SG. A synthetic adjuvant to enhance and expand immune responses to influenza vaccines. PLoS One. 2010 Oct 27;5(10):e13677. doi: 10.1371/journal.pone.0013677.

  PMID: 21060869 BACKGROUND

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Patrick Duffy, MD

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2011
• First Posted: September 14, 2011
• Study Start: August 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: February 11, 2014

Record last verified: 2014-02

Locations

US (1)