Adenovirus Type 35 Based Circumsporozoite Malaria Vaccine in Burkina Faso

NCT01018459 | Completed Phase 1

• 1 other identifier: 08-0037
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety of a malaria vaccine, Ad35.CS.01, and how the body reacts to vaccination. Participants will include 48 Berkinabè healthy males and females ages 18-45 years in Burkina Faso. Volunteers for this study will be divided into 4 groups. Members of each group (12 per group) will receive an increasing dose of vaccine or placebo (an inactive substance). Ten will receive the malaria vaccine and 2 will receive placebo. Study procedures include: physical exam, urine sample, and blood samples. Participants will be involved in study related procedures for about 13 months.

Conditions

Malaria

Keywords

malaria, vaccine, Burkina Faso

Outcome Measures

Primary Outcomes (4)

• The number of subjects experiencing severe (Grade 3) solicited injection site reactions.

  Within 14 days following vaccination.

• The number of subjects spontaneously reporting severe (Grade 3) adverse events considered associated with the vaccination.

  At any point during the study period.

• The number of subjects experiencing severe (Grade 3) solicited systemic reactions

  Within 14 days following vaccination.

• Serious adverse events considered associated with the vaccination reported.

  At any point during the study period.

Secondary Outcomes (2)

• Neutralizing antibody titers against Adenovirus type 35 by Adenovirus Neutralization Assay.

  At days 0, 28, 56, 84, 112 and 140.

• Antibody titers against the malaria circumsporozoite antigen [Geometric Mean Titer and individual log enzyme-linked immunosorbent assay (ELISA) units].

  At days 0, 28, 56, 84, 112 and 140.

Study Arms (4)

Group D: 10^11 vp/mL or placebo

EXPERIMENTAL

10 subjects will receive 10\^11 vp/mL Ad35.CS.01 and 2 subjects will receive placebo at 0, 1 and 3 months.

Biological: Ad35.CS.01 Circumsporozoite Malaria Vaccine; Drug: Placebo

Group A: 10^9 vp/mL or placebo

EXPERIMENTAL

10 subjects will receive 10\^9 viral particles (vp)/mL Ad35.CS.01 and 2 subjects will receive placebo at 0, 1 and 3 months.

Biological: Ad35.CS.01 Circumsporozoite Malaria Vaccine; Drug: Placebo

Group B: 10^10 vp/mL or placebo

EXPERIMENTAL

10 subjects will receive 10\^10 vp/mL Ad35.CS.01 and 2 subjects will receive placebo at 0, 1 and 3 months.

Biological: Ad35.CS.01 Circumsporozoite Malaria Vaccine; Drug: Placebo

Group C: 5 x 10^10 vp/mL or placebo

EXPERIMENTAL

10 subjects will receive 5 x 10\^10 vp/mL Ad35.CS.01 and 2 subjects will receive placebo at 0, 1 and 3 months.

Biological: Ad35.CS.01 Circumsporozoite Malaria Vaccine; Drug: Placebo

Interventions

Ad35.CS.01 Circumsporozoite Malaria Vaccine BIOLOGICAL

Ad35.CS.01 appears clear to slightly opalescent with no visible particles. Each 0.75 mL dose of the assigned dosage will be administered via intramuscular injection into the deltoid muscle. Dosages: 10\^9 viral particles (vp)/mL, 10\^10 vp/mL, 5 x 10\^10 vp/mL, and 10\^11 vp/mL.

Group A: 10^9 vp/mL or placebo; Group B: 10^10 vp/mL or placebo; Group C: 5 x 10^10 vp/mL or placebo; Group D: 10^11 vp/mL or placebo

Placebo DRUG

Normal saline placebo control delivered via intramuscular injection into the deltoid muscle.

Group A: 10^9 vp/mL or placebo; Group B: 10^10 vp/mL or placebo; Group C: 5 x 10^10 vp/mL or placebo; Group D: 10^11 vp/mL or placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provision of informed consent before any protocol procedures are performed.
• Males and non-pregnant, non-lactating females between the ages of 18 and 45 years, inclusive.
• Females and males must agree to practice adequate contraception until at least 28 days following their last immunization dose (including abstinence; hormonal contraception; condoms with spermicidal agents; post-menopausal; or surgical sterilization/vasectomy).
• Participants must agree to avoid high risk sexual behavior for exposure to human immunodeficiency virus (HIV).
• In good health as determined by screening medical history, physical examination (PE), and laboratory assessments.
• Willingness to comply with protocol requirements.
• Willingness to be contacted for one year for assessment of serious adverse events.
• Must be a permanent resident of the Saponé health district (villages around Balonghin) in Burkina Faso.

You may not qualify if:

• Current or recent (within the last four weeks) treatment with parenteral, inhaled, or oral corticosteroids (intranasal steroids are acceptable), or other immunosuppressive agents, or chemotherapy.
• History of splenectomy.
• Abnormal screening laboratory values. Any abnormal screening value for any screening test will exclude the subject from the study. Abnormal screening labs will not be repeated with the exception of high glucose levels will be repeated at a fasting state.
• History of intravenous (IV) drug abuse.
• History of, or current medical, occupational, social or family problems as a result of alcohol or illicit drug use.
• History of moderate to severe mental illness, as defined by symptoms interfering with social or occupational function or suicidal thoughts/attempts.
• History of receiving blood or blood products (such as blood transfusion, platelet transfusion, immunoglobulins, hyperimmune serum) in the previous 6 months.
• Vaccination with a live vaccine within the past 30 days or with a nonreplicating, inactivated, or subunit vaccine within the last 14 days.
• Known hypersensitivity to components of the vaccine.
• History of acute or chronic medical conditions including, but not limited to, disorders of the liver, kidney, lung, heart, or nervous system, or other metabolic or autoimmune/inflammatory conditions.
• History of coagulation defect or bleeding from (bruising at) multiple sites that cannot be linked to trauma or surgery.
• History of anaphylaxis or severe hypersensitivity reaction.
• Severe asthma, as defined by an emergency room visit or hospitalization within the last 12 months.
• Pregnant or breastfeeding women.
• Acute illness, including temperature \>37.8 degrees Celsius within one week prior to vaccination.

Sponsors & Collaborators

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

Study Sites (1)

Centre National de Recherche et de Formation sur le Paludisme - Research and Training

West Africa, Burkina Faso

Location

Related Publications (1)

• Ouedraogo A, Tiono AB, Kargougou D, Yaro JB, Ouedraogo E, Kabore Y, Kangoye D, Bougouma EC, Gansane A, Henri N, Diarra A, Sanon S, Soulama I, Konate AT, Watson NL, Brown V, Hendriks J, Pau MG, Versteege I, Wiesken E, Sadoff J, Nebie I, Sirima SB. A phase 1b randomized, controlled, double-blinded dosage-escalation trial to evaluate the safety, reactogenicity and immunogenicity of an adenovirus type 35 based circumsporozoite malaria vaccine in Burkinabe healthy adults 18 to 45 years of age. PLoS One. 2013 Nov 11;8(11):e78679. doi: 10.1371/journal.pone.0078679. eCollection 2013.

  PMID: 24244339 RESULT

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

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

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: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2009
• First Posted: November 23, 2009
• Study Start: April 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: June 6, 2014

Record last verified: 2012-02

Locations

BU (1)