A New Personalized Cancer Vaccine Shows Promise in Early Human Trial

A first-of-its-kind clinical trial by Harvard researchers has shown that a personalised cancer vaccine, designed for patients with advanced melanoma, is safe and can effectively activate the immune system — offering hope for future cancer treatments.

A team of researchers from Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS) has completed a Phase I human clinical trial of a new personalised cancer vaccine called WDVAX. The trial, conducted on 21 patients with stage 4 metastatic melanoma, has shown encouraging results, especially in terms of safety and immune response.

What is WDVAX?

WDVAX is a biomaterial-based cancer vaccine designed to be personalised for each patient.
It works by using the patient’s own tumor cells and antigens, placing them into a small biomaterial scaffold that helps the immune system “see” the cancer more clearly.

The goal is to train the body’s immune system to recognise and attack cancer cells — similar to how vaccines work for viruses, but far more personalised.

What the Phase I Trial Found

This early trial primarily focused on safety and feasibility, not cure rates — and the results were positive:

• All 21 participants successfully received the vaccine.
• The vaccine was well tolerated, with no serious side effects linked to treatment.
• Blood tests and immune monitoring showed strong activation of immune cells, including T-cells known for attacking tumours.
• The study confirmed that WDVAX can be produced reliably for individual patients — an important step for personalised medicine.

Researchers said this trial offers proof-of-concept that such vaccines can be safely used in humans and can stimulate the kind of immune activity needed for cancer treatment.

Why This Matters

Melanoma, especially in stage 4, is difficult to treat because cancer cells often hide from the immune system. A personalised vaccine that teaches the immune system to identify and attack tumours could be a major breakthrough.

The research team believes WDVAX may work even better when combined with immune checkpoint inhibitors — a type of immunotherapy already used in hospitals to “unblock” immune cells so they can fight cancer.

What Happens Next?

The success of this Phase I trial paves the way for:

• Larger Phase II trials
• Testing WDVAX together with checkpoint inhibitors
• Long-term studies on survival and tumor response

Researchers say the goal is not just treatment but potentially long-term cancer control — even remission — in some patients.