Necator americanus Hookworm Larvae for Bunostomiasis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
George Washington University Medical Faculty Associates, Washington, United States
Bunostomiasis+3 More
Necator americanus Hookworm Larvae - Biological
Eligibility
18 - 65
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a hookworm vaccine is safe and can prevent hookworm infection.

See full description

Eligible Conditions

  • Bunostomiasis

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Necator americanus Hookworm Larvae will improve 1 primary outcome and 2 secondary outcomes in patients with Bunostomiasis. Measurement will happen over the course of Up to Study Day 101.

Study Days 87-101
Number of adult hookworms in feces post-treatment
Month 6
Study product-related adverse events
Day 101
Fecal egg counts

Trial Safety

Safety Estimate

1 of 3

Trial Design

3 Treatment Groups

50 Necator americanus Hookworm Larvae
1 of 3
25 Necator americanus Hookworm Larvae
1 of 3
75 Necator americanus Hookworm Larvae
1 of 3
Experimental Treatment

This trial requires 30 total participants across 3 different treatment groups

This trial involves 3 different treatments. Necator Americanus Hookworm Larvae is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

50 Necator americanus Hookworm Larvae
Biological
25 Necator americanus Hookworm Larvae
Biological
75 Necator americanus Hookworm Larvae
Biological

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 months after dosing
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 6 months after dosing for reporting.

Who is running the study

Principal Investigator
M. E. B.
Maria Elena Bottazzi, PhD
Baylor College of Medicine

Closest Location

George Washington University Medical Faculty Associates - Washington, United States

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The participant signed an informed consent document, indicating their willingness to participate in the study. show original
People aged 18 to 45, both male and female. show original
The individual has a good general health, as determined by the screening procedure. show original
The text is saying that the product is available for six months. show original

Patient Q&A Section

Can bunostomiasis be cured?

"Bunostomiasis cannot be cured. The current drug treatment has the potential to be grossly underused, and to exacerbate the problem of onchocerciasis and trichinellosis. We recommend the cessation of the use of all benzimidazoles (praziquantel) and ivermectin. We also recommend the cessation of the indiscriminate use of paraquat." - Anonymous Online Contributor

Unverified Answer

What is bunostomiasis?

"Bunostomiasis affects about 10% of the population in the world and is common in Central and South America and Asia. Diagnosis is difficult with few clinical features. Infection with B. dixoni is the most common cause of bunostomiasis in the USA and the EU." - Anonymous Online Contributor

Unverified Answer

How many people get bunostomiasis a year in the United States?

"Although the global distribution of intestinal parasitic infections is well understood, the distribution in the US is poorly understood. We could not detect any significant differences between genders or regions (north or south). Results from a recent paper suggest that in the US, the global distribution of intestinal parasitic infections is not skewed (i.e., disproportionately in or out of the US) and that bunostomiasis is likely to be very common in the US because of poor sanitation." - Anonymous Online Contributor

Unverified Answer

What are common treatments for bunostomiasis?

"This work highlights a scarcity of known effective treatments for Bunostomiasis and provides a rationale for the search for efficacious drugs. It also highlights the need for well-designed controlled trials to guide the development of an effective drug for bunostomiasis." - Anonymous Online Contributor

Unverified Answer

What causes bunostomiasis?

"Results from a recent paper failed to show a statistically significant association between the consumption of water collected in ponds or rivers and the incidence of helminthiasis. This probably is because there is very little contamination of pond water and rivers with raw water. The incidence of helminthiasis is high among the villagers. Waterborne helminths could be a major cause of diarrhoea and anaemia, but the main parasite in the study was the gastrointestinal trematodes which is often asymptomatic." - Anonymous Online Contributor

Unverified Answer

What are the signs of bunostomiasis?

"There are no specific signs of bunostomiasis, but the appearance is similar to that of filariasis. Patients with filariasis may present in a similar way to patients with the filarial worms, with an absence of significant itching, no lymphadenopathy and no lymphatics nodules. The absence of lymphadenopathy and lymphatics nodules helps distinguish filariasis from bunostomiasis. Filarian nematodes can grow to very large sizes and can live for many years. However, the worms in bunostomiasis are smaller than 10mm and usually go undetected for many years. Filariae are often transmitted from infected persons to others." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of necator americanus hookworm larvae?

"The side effects associated with hookworm larvae in our study population are similar to recent reports from other tropical areas, namely intestinal obstruction, peritonitis, hepatic abscess formation, chronic subcutaneous fistula formation, and arthritis. Hookworm infection is also associated with an increased risk of thrombocytopenia and leukopenia." - Anonymous Online Contributor

Unverified Answer

What is necator americanus hookworm larvae?

"Findings from a recent study we report hooks identified in the intestine of infected patients in Brazil. The parasite was not morphologically similar to other larval forms, but similar to necator larvae described in the past. This species may represent a new strain or a morphological variant of previously reported species. Our initial hypothesis that the larvae were in the intestine reflects the initial location of the mature larvae." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in necator americanus hookworm larvae for therapeutic use?

"Hookworm larvae have been successfully used as a therapeutic agent against an infection, for instance in the treatment of cutaneous leishmaniasis and onchocerciasis. Also, it was found to be a promising candidate for adjunctive treatment to chemotherapy of intestinal round worm infections (i.e., intestinal roundworm infection as a model of intestinal roundworm infection)." - Anonymous Online Contributor

Unverified Answer

Has necator americanus hookworm larvae proven to be more effective than a placebo?

"Results from a recent paper, there was no statistical difference between Necator hookworm treatment and placebo but Necator hookworms showed higher efficacy on improving the immune responsiveness and on the clinical evolution. Results from a recent paper could be used as references and a starting point in future research that aims to produce a hookworm vaccine." - Anonymous Online Contributor

Unverified Answer

Is necator americanus hookworm larvae typically used in combination with any other treatments?

"Hookworm infection is a major burden in rural areas where the prevalence of intestinal helminthiasis is high. Results from a recent clinical trial suggests that hookworm infection is an important pathogen that needs to be considered for the elimination of helminthiasis in rural areas." - Anonymous Online Contributor

Unverified Answer

Is necator americanus hookworm larvae safe for people?

"Hookworm in stool of untreated people may be associated with increased odds of death due to pneumonia. In the population surveyed, the prevalence of infection with hookworm was moderate. These data suggest that hookworm infection has little short-term impact in South East Asia. In a recent study, findings are discussed and further trials in China planned for 2017-2019." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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