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Safety and Immunogenicity of the Placental Malaria Vaccine Candidate PAMVAC Variously Adjuvanted (PAMVAC)

This study is currently recruiting participants.
Verified October 2016 by University Hospital Tuebingen
Sponsor:
ClinicalTrials.gov Identifier:
NCT02647489
First Posted: January 6, 2016
Last Update Posted: October 31, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
University of Copenhagen
Université d'Abomey-Calavi
European Malaria Vaccine Initiative
Institut de Recherche pour le Developpement
Expres2ion Biotechnologies APS
Information provided by (Responsible Party):
University Hospital Tuebingen
  Purpose

Despite having developed robust acquired immunity against complications of malaria, women can return to a susceptible state during their first pregnancies and contribute significantly to the burden of severe malaria in highly endemic areas. Naturally acquired protection against placental malaria correlates with the presence of high concentration of immunoglobulin G molecules (IgGs) against VAR2CSA, a parasite protein of the var gene family that is essential for the binding of infected erythrocytes to CSA in the placenta.

To induce high concentrations of specific IgGs, subjects will receive escalating doses of PAMVAC vaccine antigen adjuvanted with Alhydrogel, Glucopyranosyl Lipid Adjuvant-Stable Emulsion (GLA-SE) or Glucopyranosyl Lipid Adjuvant-Liposome-QS-21 Formulation (GLA-LSQ). Three injections with the same dosage and adjuvant will be done, each 28 days apart (Day 0, 28 and 56). Control subjects will receive physiological saline instead of the vaccine and dose escalation will be staggered to ensure safety during the trial.


Condition Intervention Phase
Malaria, Antepartum Biological: PAMVAC Biological: Alhydrogel Biological: GLA-SE Biological: GLA-LSQ Other: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of the Placental Malaria Vaccine Candidate PAMVAC Adjuvanted With Alhydrogel, GLA-SE or GLA-LSQ in Healthy Malaria-Naïve Adults and Healthy, Lifelong Malaria-Exposed, Nulligravid Adult Women

Resource links provided by NLM:


Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • Number and grade of adverse events (Grade 1-3 and serious adverse events) possibly, likely and definitely related to vaccination [ Time Frame: From the first administration of the interventions through study completion, an average of 1 and a half years ]

Secondary Outcome Measures:
  • Area under the curve of anti-PAMVAC IgG concentration [ Time Frame: Before first administration, 1, 4, 5, 8, 9, 12, 24 and 36 weeks after first administration ]

Estimated Enrollment: 66
Study Start Date: May 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1A - 20 µg PAMVAC + Alhydrogel
The study participant will get 20 µg of PAMVAC adjuvanted with Alhydrogel administrated three times with each time 28 days interval (day 0-28-56)
Biological: PAMVAC Biological: Alhydrogel
Experimental: 2A - 20 µg PAMVAC + GLA-SE
The study participant will get 20 µg of PAMVAC adjuvanted with GLA-SE administrated three times with each time 28 days interval (day 0-28-56)
Biological: PAMVAC Biological: GLA-SE
Experimental: 3A - 20 µg PAMVAC + GLA-LSQ
The study participant will get 20 µg of PAMVAC adjuvanted with GLA-LSQ administrated three times with each time 28 days interval (day 0-28-56)
Biological: PAMVAC Biological: GLA-LSQ
Experimental: 4A - 50 µg PAMVAC + Alhydrogel
The study participant will get 50 µg of PAMVAC adjuvanted with Alhydrogel administrated three times with each time 28 days interval (day 0-28-56)
Biological: PAMVAC Biological: Alhydrogel
Experimental: 5A - 50 µg PAMVAC + GLA-SE
The study participant will get 50 µg of PAMVAC adjuvanted with GLA-SE administrated three times with each time 28 days interval (day 0-28-56)
Biological: PAMVAC Biological: GLA-SE
Experimental: 6A - 50 µg PAMVAC + GLA-LSQ
The study participant will get 50 µg of PAMVAC adjuvanted with GLA-LSQ administrated three times with each time 28 days interval (day 0-28-56)
Biological: PAMVAC Biological: GLA-LSQ
Experimental: 1B - 50 µg PAMVAC + Alhydrogel
The study participant will get 50 µg of PAMVAC adjuvanted with Alhydrogel administrated three times with each time 28 days interval (day 0-28-56)
Biological: PAMVAC Biological: Alhydrogel
Experimental: 2B - 50 µg PAMVAC + GLA-SE
The study participant will get 50 µg of PAMVAC adjuvanted with GLA-SE administrated three times with each time 28 days interval (day 0-28-56)
Biological: PAMVAC Biological: GLA-SE
Experimental: 3B - 100 µg PAMVAC + Alhydrogel
The study participant will get 100 µg of PAMVAC adjuvanted with Alhydrogel administrated three times with each time 28 days interval (day 0-28-56)
Biological: PAMVAC Biological: Alhydrogel
Experimental: 4B - 100 µg PAMVAC + GLA-SE
The study participant will get 100 µg of PAMVAC adjuvanted with GLA-SE administrated three times with each time 28 days interval (day 0-28-56)
Biological: PAMVAC Biological: GLA-SE
Placebo Comparator: 5B - Placebo
The study participant will get Placebo (physiological saline solution) administrated three times with each time 28 days interval (day 0-28-56)
Other: Placebo

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and female volunteers aged 18-45 years.
  • Able and willing (in the investigator's opinion) to comply with all trial requirements.
  • General good health based on history and clinical examination
  • Written informed consent
  • Women only: Must agree to practice continuous effective contraception for the duration of the trial (a method which results in a low failure rate; i.e. less than 1% per year). Women will be counseled about effective contraception methods and, if required, can be provided with adequate contraceptives by the investigator team.
  • Available to participate in follow up for the duration of trial (36 weeks following first injection)
  • Reachable by phone during the whole trial period

Exclusion Criteria:

  • Pregnancy, lactation or intention to become pregnant during the trial
  • Previous participation in a malaria vaccine trial
  • HIV infection
  • Any confirmed or suspected immunosuppressive or immunodeficient state, asplenia, recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed)
  • Presence of autoimmune diseases requiring systemic treatment (e.g. rheumatic diseases)
  • Use of immunoglobulins or blood products within 3 months prior to enrolment
  • Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt during the trial period
  • History of malaria or travel in malaria-endemic areas within the past 6 months
  • Intention to travel to malaria endemic countries during the trial period
  • History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
  • History of serious psychiatric condition that may affect participation in the trial
  • Any other serious chronic illness requiring hospital specialist supervision
  • Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 60 g (men) or 40 g (women) per day or a carbohydrate deficient transferrin (CDT) level ≥2.5%
  • Suspected or known injecting drug abuse in the 5 years preceding enrolment
  • Positive for hepatitis B surface antigen (HBs-antigen)
  • Seropositive for hepatitis C virus (antibodies to HCV)
  • Volunteers unable to be closely followed for social, geographic or psychological reasons
  • Known hypersensitivity to any of the vaccine components (adjuvant or peptide)
  • Any clinically significant abnormal finding on biochemistry or hematology blood tests, urine analysis or clinical examination
  • History of seizure, except for sporadic febrile convulsions in childhood
  • Any other significant disease, disorder or finding which, in the opinion of the investigator, may significantly increase the risk to the volunteer because of participation in the trial; affect the ability of the volunteer to participate in the trial or impair interpretation of the trial data.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02647489


Contacts
Contact: Diane Egger-Adam, Dr. +4970712982191 diane.egger-adam@uni-tuebingen.de

Locations
Benin
Institut de Recherche Clinique du Benin (IRCB) Recruiting
Abomey-Calavi, Benin
Contact: Saadou Issifou, Dr. med    +229 61632260    isaadou2002@yahoo.fr   
Sponsors and Collaborators
University Hospital Tuebingen
University of Copenhagen
Université d'Abomey-Calavi
European Malaria Vaccine Initiative
Institut de Recherche pour le Developpement
Expres2ion Biotechnologies APS
Investigators
Principal Investigator: Benjamin G Mordmüller, MD University Hospital Tübingen
Principal Investigator: Saadou Issifou, MD Université d'Abomey-Calavi
  More Information

Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT02647489     History of Changes
Other Study ID Numbers: PAMVAC1_15
First Submitted: January 4, 2016
First Posted: January 6, 2016
Last Update Posted: October 31, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Aluminum Hydroxide
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents