Molecular Neurodegeneration

Alzheimer’s vaccine prompts an immune response in 12 adults

All 12 vaccine recipients developed antibodies after two doses, while four placebo recipients showed no measurable response in a randomized phase 1 trial.

Figure 1 from Molecular Neurodegeneration
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Figure 1. Hovakimyan et al.
Studied:
Randomized trial in 16 people (Double-blind, placebo-controlled, registered ACTRN12624000737538)

Editor of record: Boris Djordjevic · AgingResearch.News

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Sixteen healthy adults aged 40–60, including 12 men and four women, joined a randomized, double-blind, placebo-controlled phase 1 trial of AV-1959R. Twelve received 100 or 300 micrograms of vaccine; four received placebo. Both included an immune-boosting ingredient. Injections took place on day 1 and at weeks 4 and 14. Safety follow-up continued through week 22.

After two injections, all 12 vaccine recipients developed antibodies against amyloid-beta, a protein that forms plaques in Alzheimer’s disease. Placebo recipients showed no measurable response. Laboratory tests found that the antibodies favored disease-linked clumped forms of the protein. Across both groups, 14 participants reported 56 adverse events: 49 mild and seven moderate. Injection-site reactions affected 10 vaccine recipients and two placebo recipients. No serious adverse events occurred. All adverse events resolved.

Why it matters

Amyloid buildup is a target for preventing Alzheimer’s before symptoms appear. The authors aim to test whether vaccination can clear, reduce or slow that buildup and delay the disease’s onset.

Caveats

The trial assessed safety and antibody responses, not whether vaccination reduced brain amyloid or prevented Alzheimer’s. All 16 participants were healthy white adults aged 40–60, so the results do not establish effects in older adults or people with Alzheimer’s.

Where the evidence stands

Immune response

Cells, worms or flies, mice and humans: replicated by independent labs.
  • 302 independent labs in 46 countries
  • 30 findings against
  • Funders: National Institutes of Health and others
  • 84 of 548 findings with company ties

APP

Mice: replicated by independent labs. Cells, worms or flies and humans: a single group.
  • 89 independent labs in 24 countries
  • 4 findings against
  • 56 trials, 9 with no results posted
  • Funders: National Institute on Aging and others
  • 31 of 208 findings with company ties
  • 55 of 56 trials sponsored by developers of drugs aimed at it

From the paper

Participants

Remaining 16 participants were randomized into one of two sequential cohorts in a 3:1 ratio to receive intramuscular injections of either AV-1959R (n = 12) or placebo (n = 4), both formulated with Advax-CpG55.2 adjuvant at baseline and week 4 (e.g., priming immunizations) …

Results, Study participants

Harms

AV-1959R was safe and well-tolerated, with no serious adverse events or ARIA observed.

Results

Quoted word for word from the full text on link.springer.com.

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