FDA Approves Phase 1 Clinical Trial Of Zika Vaccine

Inovio Pharmaceutical, Inc. and GeneOne Life Sciences have recently announced that they have received approval to conduct a Phase1 clinical trial of their new vaccine, GLS-5700, on human subjects, from the Food and Drug Administration (FDA).

In a press release, Inovio President and CEO Dr J. Joseph Kim said, “We are proud to have attained the approval to initiate the first Zika vaccine study in human volunteers”. He also added, “we are planning to dose our first human subject next week and the results of the first human trial will be out by the end of this year.” The expectations are high after the vaccine gave a robust immunogenic response in rats and monkeys in the labs.”

Inovio decided to enroll 40 healthy human subjects for this trial and will be administering this DNA vaccine (GLS-5700) intradermally with the help of CELLECTRA, Inovio’s proprietary DNA delivery device.

Amidst pre-clinical trials, the immunogenic reactions have been observed on lab animals and fortunately, antibodies stimulate a strong antibody response against the viral antigen.

After the successful pre-clinical trials, clinical trials will be done on humans but within the research ethical range. . The purpose of the human clinical trial is to check the safety, tolerability and efficacy of this vaccine on human subjects. For this vaccine, the site of injection will be given a small electrical shock which will bring the DNA to the cells. Later on, the cells will train the body’s immune response system to attack the Zika virus entering the body. This process of injection with the help of electrical shock is known as electroporation.

GLS-5700, also known as DNA vaccine, works like other vaccines by stimulating an immune response in the body against the antigen or Zika virus in this case. It translated into a protein that surrounds the Zika virus in the body. In pre-clinical trials, to check the immunogenicity of this vaccine, a synthetic viral DNA fragment has been injected to the body to see the immune response.

Inovio Pharmaceutical is a Pennsylvania-based vaccine Company which has multiple vaccines in the pipeline for both infectious diseases and cancer. It previously conducted a phase 2 trial on its cancer vaccine and will conduct a phase 3 trial on it very soon. There are around 15 pharmaceutical companies developing vaccines for Zika, but sadly most of them lack approval while others have not yet met the clinical trial criteria. Moreover, Indian company, Bharat Biotech and the National Institute of Allergy and Infectious Diseases are also working on developing Zika vaccines.

Zika spreads through the bite of a tropical virus known as aedes aegypti. It has various modes of transmission such as mother to child, blood transfusion, travel and as recently discovered, through sexual contact. The Zika mosquito normally lays eggs on open water fields, uncovered pots or water containing basins.  According to FDA, around one laboratory-acquired,  755 travel-associated and 11 sexually transmitted Zika cases have been reported in the US.

As a result, making this vaccine tolerable and effective for humans is a challenging task for both companies. However, the company is confident after witnessing the results shown in the pre-clinical trials.

Mr. Young K. Park, GeneOne Life Science’s President & CEO, said, “it is an honor for our company to usher this Zika vaccine through the clinical and regulatory process. Added that, we are looking forward to conducting this trial with the goal of achieving products to combat this dreaded virus.”

Nonetheless, FDA is concerned about the outcomes of this phase 1 trial, since the vaccination will be needed by pregnant women and should therefore be safe and effective. Karen Kotloff, a pediatric professor and head of the division of infectious disease at the University of Maryland said that it took 10-15 years for a single vaccine to reach the market. Similarly, when this vaccine will be publically available remains an unanswered question.

Inovio and GeneOne are developing this vaccine in collaboration with the US and Canadian governments. Inovio President, Kim said in an interview currently we are lacking the production facilities but in the near time we will manage to gather the resources.

An increment of 4% appeared in Inovio Pharmaceutical Inc’s stocks after the disclosure of the FDA’s approval. Furthermore,  Inovio has gained an approximate 50% increase in their stock since the start of this year which, as of 12:32 PM EDT, is up by 3.63% at $10.85.

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