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MCD Inc.


The Mission

The goal of the EGMVI is to eliminate malaria transmission on Bioko Island as such to eliminate malaria-attributable morbidity and mortality, improve the welfare of Equatoguineans and improve conditions for economic development. To reach this goal the EGMVI seeks to conduct a series of clinical trials to evaluate and help bring to licensure a whole-parasite whole-parasite sporozoite vaccines, Sanaria ® PfSPZ Vaccine, that confer high-level, long-lasting protection against Plasmodium falciparum, the malaria parasite responsible as much as 1/3rd of the morbidity in Equatorial Guinea and more than 95% of malaria associated severe illness and death world-wide and the malaria parasite for which there is the most significant drug resistance.

An further essential objective of these clinical trials being conducted on Bioko Island, Equatorial Guinea, is to carry-out the operations research required to evaluate alternative delivery strategies and to inform planning for a mass (island-wide) vaccination campaign to ultimately eliminate malaria from Bioko with a licensed PfSPZ Vaccine.

The EGMVI is designed to be integrated within the on-going Bioko Island Malaria Control Project (BIMCP) which started in 2003 and will continue through 2018. The BIMCP is seeking to reduce malaria transmission on Bioko Island to pre-elimination levels through an integrated set of control interventions including vector control through indoor residual spraying, the use of long lasting insecticide treated nets, and focal source reduction; passive and active case detection and treatment; information, education and communications for behavioral change; monitoring and evaluation for evidenced-based programming; and, capacity building and institutional development to transfer the competencies for sustained malaria control management to the National Malaria Control Program.

The History

The first stage of the Equatorial Guinea Malaria Vaccine Initiative (EGMVI) was carried out in 2012 and early 2013 to explore with the Government of Equatorial Guinea (GoEG) the feasibility and desirability of putting in place the conditions precedent for conducting a first small scale clinical trial to establish the safety, tolerability, immunogenicity and protective efficacy of one of Sanaria® sporozoite-based malaria vaccines. This first stage included technical visits by vaccine experts to Equatorial Guinea, including from WHO-AFRO, visits by Equato-Guinean health authorities to witness and learn about a first clinical trial of the PfSPZ Vaccine in Bagamoyo, Tanzania, conducted by the Ifakara Health Institute, and culminated in a visit by His Excellency, the President of Equatorial Guinea, Theodoro Obiang Nguema Mbasogo to Sanaria in Rockville Maryland to observe firsthand the vaccine production process and to discuss the future potential role that Equatorial Guinea could play in the development and commercialization of the vaccine.

At the end of the first stage, the Government of Equatorial Guinea decided to move forward with and authorize funding in August 2013. An agreement for financing the second stage was signed between the Government of Equatorial Guinea, Marathon Oil, AMPCO and Noble Energy, and MCDI was contracted by Marathon Oil to provide operational management and logistical support for its implementation in collaboration with a Vaccine Implementation Team composed of Equatoguinean Nationals and personnel from Ifakara Health Institute, Sanaria, Inc. and La Paz Malabo Medical Center.

The objective of the second stage was to put in place the conditions precedent for conducting a first-of-its kind small scale clinical trial in Equatorial Guinea, and then to carry out the trial. The trial is expected to culminate in October 2015.The initial conditions precedent for conducting the first-ever clinical trial in Equatorial Guinea involved establishing a National Ethics Committee (NEC) to review, approve and monitor biomedical and behavioral research involving humans, including the proposed clinical trials for a Sanaria vaccine. The purpose of the NEC review was to assure, both in advance and by periodic review, that appropriate steps were taken to protect the rights and welfare of humans participating as subjects in the clinical trials. The NEC was constituted to ensure protection of subjects by reviewing and approving (or modifying or rejecting) research protocols and related materials. The NEC protocol review assessed the ethics of the research and its methods, promoting fully informed and voluntary participation by prospective subjects capable of making such choices (or, in cases where that was not possible, informed permission given by a suitable proxy), and sought to maximize the safety of subjects. Throughout the trial, the NEC is responsible for evaluating any adverse events and periodically reviewing the progress and safety of the trial.

The next conditions precedent involved engaging the National Regulatory Authority (NRA) within the Ministry of Health and Social Welfare (MOHSW) of Equatorial Guinea to review and approve the importation of the Sanaria® PfSPZ Vaccine and other products to be used in the clinical trials, ensuring that these imported products satisfied the safety, efficacy and quality requirements of the Government of Equatorial Guinea, the World Health Organization and the US Food and Drug Administration. The NRA that currently exists within the MOHSW is the Director General of Pharmacies and Traditional Medicine.

In addition to assisting in setting up the appropriate review committees and engaging the regulatory authorities, the EGMVI contributed to training 5 Equatoguinean nationals to participate in the first clinical trials in Bioko Island. Four of these individuals participated in a training course at the Ifakara Health Institute in Bagamoyo, Tanzania, where they worked closely with a team from Ifakara to better understand the requirements for running a vaccine trial and to be prepared to assist with the first clinical trials in Equatorial Guinea. In Equatorial Guinea, all five nationals also participated in continual training sessions with the IHI team. The goal is that these individuals will be well equipped to take on leadership roles in subsequent trials throughout the third stage.

Stage 2 Activity Highlights, 2014

The First Quarter

2014 Annual Planning Meeting: On March 24th and 25th, representatives from Sanaria and Ifakara came to Malabo, Equatorial Guinea to participate in the 2014 Annual Planning Meeting. They were joined by representatives from the Ministry of Health and Social Welfare, Ministry of Interior, Ministry of Education, and others to discuss the activities accomplished in 2013 and plans for 2014.

Completion of Clinical Trial Protocol: The English version of the clinical trial was completed in the first quarter of 2014. Translation into Spanish for submission to the National Ethics Committee of Equatorial Guinea began during the first quarter as well.

Arrival of team from Ifakara Health Institute: The EGMVI welcomed three members of the Ifakara Health Institute to Malabo, Equatorial Guinea in March 2014. These individuals will reside in Malabo for the duration of the trial.

The Second Quarter

Capacity building trip to a clinical trial site in Mali: In May 2014, four Equatoguinean nationals, and representatives of MCDI and Marathon Oil visited Bamako, Mali to visit the Malaria Research Training Center and a clinical trial site carrying out a Phase I trial with Sanaria® PfSPZ Vaccine.

Translation of Clinical Trial Protocol and associated documents: The clinical trial protocol and supported documents were finalized and translated into Spanish during the second quarter. They were readied to submit to the National Ethics Committee of Equatorial Guinea.

Finalization of the SOPs of the Ethics Committee and agreement to sign Memorandum of Cooperation with the Tanzanian National Health Research Ethics Committee: In April, the NECEG held a two-day meeting in Bata to finalize their SOPs and create a Committee Logo. In early June, the president, vice-president and two secretaries signed the first version of the SOPs, making them official.

Selection of clinical trial nurse: Interviews for a clinical trial nurse were held at the end of May, 2014, and a candidate was selected to be the clinical trial nurse. The Ministry of Health approved her secondment to MCDI, and she officially started work on July 1, 2014.

Improvements to the clinical trial Laboratory: After a pre-trial site visit by Sanaria, the EGMVI team began working with the La Paz Medical Center staff to make improvements to the laboratory, including creation of SOPs, improvement of documentation practices and improved training records.

The Third Quarter

First meeting of the Safety Monitoring Committee: In September, Sanaria® organized the first meeting of the Safety Monitoring Committee (SMC). The four members of the SMC, plus representatives from Sanaria, Ifakara and the MoHSW EG met via teleconference to go over the trial design and discuss the SMC Charter.

Completion of Case Report Forms: The field team completed the creation of all Case Report Forms to be used for documenting information throughout the clinical trial.

Simulation and training of the vaccine shipment: A Sanaria representative came to Equatorial Guinea in September to train the team on vaccine reception and maintenance.

Introductory meetings with Community leaders in Baney and Rebola: The local EG staff organized meetings with community leaders and health care workers in Baney and Rebola to introduce these individuals to the idea of a clinical trial, and explain to them future plans for the involvement of their communities.

The Fourth Quarter

Submission of study protocol to Equatorial Guinea National Ethics Committee: On October 31, 2014, the EGMVI officially submitted the study protocol and supporting documents to the Equatorial Guinea National Ethics Committee (CENGE, for its acronym in Spanish). Under their guidelines, the CENGE had 60 working days to review the protocol.

Simulation of Screening and Vaccination Days: The EGMVI team conducted a two-day simulation at La Paz Medical Center. Eight mock volunteers went through a simulation of a Screening and Vaccination day in order to allow the clinical team to practice the procedures and familiarize themselves with the study flow.

State 2 Activity Highlights, 2015

The First Quarter

Regulatory approval received to carry-out first small-scale clinical trial with the PfSPZ Vaccine: On January 22, 2015, following a presentation of the protocol by principal investigator from IHI, the National Ethics Committee of Equatorial Guinea approved the study protocol for the first small-scale clinical trial to be conducted in Equatorial Guinea. Ethics committee approval was also obtained from the IHI-IRB and MaGil, a US IRB.

Site initiation visit completed by Clinical Trial Monitors: SwissTPH, which serve as the Clinical Trial Monitor (CTM) for the EGSPZV1 trial, visited the site between January 19th and 21st to conduct a site initiation visit. During this time, the CTM reviewed all study documents and clinical sites, and provided a report to the site. Following completion of pending action items, the CTM provided their approval to start the clinical trial in Equatorial Guinea.

Community recruitment meetings: The first two pre-selection community meetings were held in Baney and Rebola on March 2 and 16, respectively. Interested and eligible volunteers were invited to attend screening visits at La Paz Medical Center following the recruitment meeting.

Injection of first three volunteers with the PfSPZ Vaccine: On March 7th, following successful recruitment and screening visits,three volunteers were injected with the PfSPZ Vaccine at La Paz Medical Center Sipopo, Malabo.